Pain Control Following Sinus Surgery

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03783702
• Collaborator: Mayo Clinic (Other), Vanderbilt University Medical Center (Other), Albert Einstein College of Medicine (Other), University of British Columbia (Other), NorthShore University HealthSystem (Other)
• Enrollment: 118
• Locations: 6
• Arms: 2
• Actual Duration (Months): 20.9
• Patients Per Site: 19.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI).

The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.

Condition or Disease	Intervention/Treatment	Phase
Sinusitis; Opioid Use; Opioid Abuse; Narcotic Use; Otolaryngologic Disease; Postoperative Pain; Pain	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet; Drug: Ibuprofen 600 Mg (milligram) Oral Tablet; Drug: Acetaminophen 650 MG (milligram) Oral Tablet	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
• Actual Study Start Date: Apr 4, 2019
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet; Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.; Drug: Ibuprofen 600 Mg (milligram) Oral Tablet; Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.; Drug: Acetaminophen 650 MG (milligram) Oral Tablet; All patients will receive acetaminophen as the first-line analgesic.
Active Comparator: Control group Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet; Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.; Drug: Acetaminophen 650 MG (milligram) Oral Tablet; All patients will receive acetaminophen as the first-line analgesic.

Outcome Measures

Primary Outcome Measures

1. Pain Severity [Average pain score will be collected for preoperative visit (the day before surgery)]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

2. Pain Severity [Average pain score was collected for postoperative day 1]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

3. Pain Severity [Average pain score will be collected for postoperative day 2]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

4. Pain Severity [Average pain score will be collected for postoperative day 3]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

5. Pain Severity [Average pain score will be collected for postoperative day 4]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

6. Pain Severity [Average pain score will be collected for postoperative day 5]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

7. Pain Severity [Average pain score will be collected for postoperative day 6]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

8. Pain Severity [Average pain score will be collected for postoperative day 7]

   A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

9. Medication Log [Postoperative day 1 to 7]

   Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.

Secondary Outcome Measures

1. Brief Pain Inventory (BPI) Score [BPI score will be collected at the preoperative visit]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

2. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 1]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

3. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 2]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

4. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 3]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

5. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 4]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

6. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 5]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

7. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 6]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

8. Brief Pain Inventory (BPI) Score [Average BPI score will be collected for postoperative day 7]

   The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

9. Severity of Epistaxis [Epistaxis severity will be collected at the preoperative visit]

   A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

10. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 1]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

11. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 2]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

12. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 3]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

13. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 4]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

14. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 5]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

15. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 6]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

16. Severity of Epistaxis [Epistaxis severity will be collected for postoperative day 7]

    A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• English-speaking

• Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)

• Can commit to follow up for at least one postoperative visit

Exclusion Criteria:

Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery)

• Doyle splints to be used

• Alcohol or opioid use disorder

• History of chronic pain disorders

• Regular use of acetaminophen/NSAIDS (>4x per week)

• Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average.

• Gastrointestinal ulcers or bleeding

• Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate <60)

• Liver cirrhosis or other hepatic impairment

• Prior adverse reaction to opioids or NSAIDS

• Other contraindications to any drug classes in either group.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Health Care	Stanford	California	United States	94305
2	NorthShore University Health System	Evanston	Illinois	United States	60201
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Albert Einstein	Bronx	New York	United States	10461
5	Vanderbilt	Nashville	Tennessee	United States	37232
6	University of British Columbia	Vancouver		Canada

Sponsors and Collaborators

• Stanford University
• Mayo Clinic
• Vanderbilt University Medical Center
• Albert Einstein College of Medicine
• University of British Columbia
• NorthShore University HealthSystem

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 7, 2018

More Information

Publications

• Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.
• Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.
• Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.
• Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.

• Responsible Party: Peter Hwang, Principal Investigator, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03783702
• Other Study ID Numbers: 46384
• First Posted: Dec 21, 2018
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Sinusitis; Otorhinolaryngologic Diseases; Opioid-Related Disorders; Acetaminophen; Ibuprofen; Oxycodone

Study Results

Participant Flow

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Period Title: Overall Study
STARTED	56	62
COMPLETED	49	51
NOT COMPLETED	7	11

Baseline Characteristics

Arm/Group Title	Experimental Group	Control Group	Total
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	Total of all reporting groups
Overall Participants	49	51	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (16.1)	43.3 (15.9)	46.7 (16.3)
Sex: Female, Male (Count of Participants)
Female	22 44.9%	22 43.1%	44 44%
Male	27 55.1%	29 56.9%	56 56%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 6.1%	4 7.8%	7 7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 8.2%	3 5.9%	7 7%
White	40 81.6%	43 84.3%	83 83%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 4.1%	1 2%	3 3%
Prior sinus surgery (Count of Participants)
Count of Participants [Participants]	21 42.9%	18 35.3%	39 39%
Lund-mackay score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.7 (4.8)	11.4 (5.9)	10.5 (5.4)
Total baseline SNOT-22 score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	39.6 (20.1)	41.4 (19.8)	40.5 (19.9)

Outcome Measures

1. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for preoperative visit (the day before surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	12.4 (20.0)	8.5 (13.5)

2. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score was collected for postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	30.2 (26.6)	29.4 (26.0)

3. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for postoperative day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	27.0 (24.8)	23.5 (23.2)

4. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for postoperative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	19.2 (22.6)	22.5 (19.0)

5. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for postoperative day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	14.1 (18.7)	16.8 (18.1)

6. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for postoperative day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	15.8 (21.8)	15.0 (19.6)

7. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for postoperative day 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	13.9 (19.0)	11.7 (14.5)

8. Primary Outcome

Title	Pain Severity
Description	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Time Frame	Average pain score will be collected for postoperative day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	8.1 (9.8)	10.1 (11.2)

9. Primary Outcome

Title	Medication Log
Description	Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.
Time Frame	Postoperative day 1 to 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Oxycodone POD1	0.3 (0.7)	0.6 (1.1)
Oxycodone POD2	0.1 (0.3)	0.4 (1.0)
Oxycodone POD3	0.1 (0.2)	0.3 (0.8)
Oxycodone POD4	0.1 (0.3)	0.3 (0.7)
Oxycodone POD5	0.1 (0.4)	0.3 (1.1)
Oxycodone POD6	0.1 (0.3)	0.1 (0.6)
Oxycodone POD7	0 (0.2)	0 (0.2)
Acetaminophen POD1	2.0 (1.5)	2.1 (1.8)
Acetaminophen POD2	1.8 (1.4)	1.9 (1.9)
Acetaminophen POD3	1.3 (1.3)	1.6 (1.6)
Acetaminophen POD4	1.0 (1.5)	1.5 (1.4)
Acetaminophen POD5	0.9 (1.2)	1.3 (1.4)
Acetaminophen POD6	0.9 (1.3)	1.1 (1.3)
Acetaminophen POD7	0.6 (1.0)	0.6 (0.8)
Ibuprofen POD1	0.6 (0.9)	0 (0)
Ibuprofen POD2	0.5 (0.8)	0 (0)
Ibuprofen POD3	0.4 (0.9)	0 (0)
Ibuprofen POD4	0.3 (0.8)	0 (0)
Ibuprofen POD5	0.4 (0.8)	0 (0)
Ibuprofen POD6	0.3 (0.6)	0 (0)
Ibuprofen POD7	0.2 (0.5)	0 (0)

10. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	BPI score will be collected at the preoperative visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	1.6 (2.2)	1.0 (1.5)

11. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	2.8 (2.3)	2.9 (2.0)

12. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	2.5 (2.1)	2.3 (2.0)

13. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	1.9 (2.0)	2.1 (1.8)

14. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	1.5 (1.8)	1.9 (1.6)

15. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	1.7 (2.1)	1.6 (1.6)

16. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	1.5 (1.9)	1.4 (1.5)

17. Secondary Outcome

Title	Brief Pain Inventory (BPI) Score
Description	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Time Frame	Average BPI score will be collected for postoperative day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	1.3 (1.7)	1.4 (1.5)

18. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected at the preoperative visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	0 (0)	0 (0)

19. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	36.3 (33.2)	38.9 (31.9)

20. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	23.0 (27.1)	21.6 (24.0)

21. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	15.9 (22.0)	12.9 (17.5)

22. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	9.3 (15.2)	11.8 (16.5)

23. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	10.1 (20.1)	7.8 (17.5)

24. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	6.5 (11.6)	6.6 (14.1)

25. Secondary Outcome

Title	Severity of Epistaxis
Description	A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Time Frame	Epistaxis severity will be collected for postoperative day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
Measure Participants	49	51
Mean (Standard Deviation) [units on a scale]	4.6 (9.2)	5.4 (12.5)

Adverse Events

Time Frame	Adverse events were collected during the one week period after surgery for each participant.
Arm/Group Title	Experimental Group		Control Group
Arm/Group Description	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics		st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
All Cause Mortality
	Experimental Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Serious Adverse Events
	Experimental Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)

Limitations/Caveats

The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use Selection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up Lack of blinding and placebo were additional limitations

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.