Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT03404518
Collaborator
(none)
185
2
2
7.3
92.5
12.7
Study Details
Study Description
Brief Summary
Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.
The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.
Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.
Study Design
Study Type:
Interventional
Actual Enrollment
:
185 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Quantifying Narcotic Use in Outpatient Otolaryngology Procedures
Actual Study Start Date
:
Feb 21, 2018
Actual Primary Completion Date
:
Oct 1, 2018
Actual Study Completion Date
:
Oct 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Norco and Ibuprofen This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. |
Drug: Norco
Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
Other Names:
|
| Active Comparator: Ibuprofen and Norco This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. |
Drug: Ibuprofen
Ibuprofen as first line therapy every 6 hours as needed for pain control
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Narcotic Usage [First 7 days after surgery]
The average number of narcotic pills needed or used for pain control
Secondary Outcome Measures
- Patient Pain Level [Average reported pain for first 7 days after surgery]
The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.
- Ibuprofen Usage [First 7 days after surgery]
The average number of ibuprofen pills needed or used for pain control
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Patients undergoing one of the following outpatient procedure:
-
Septoplasty
-
Unilateral or Bilateral Functional endoscopic sinus surgery
-
Tympanomastoidectomy
-
Tympanoplasty
-
Total or Partial Thyroidectomy
-
Parathyroidectomy
-
Parotidectomy.
-
Age >18 years and < 89 years
Exclusion Criteria:
-
Age < 18 years or > 89 years
-
Post operative hospital admission
-
Allergy to Hydrocodone
-
Allergy or contraindication to Ibuprofen or NSAIDs
-
Pregnancy
-
Hepatic disease
-
Chronic kidney disease
-
Sickle cell anemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 2 | Loma Linda University Surgical Hospital | Loma Linda | California | United States | 92354 |
Sponsors and Collaborators
- Loma Linda University
Investigators
- Principal Investigator: Jared Inman, MD, Loma Linda University Health System
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Foghsgaard S, Foghsgaard J, Homøe P. Early post-operative morbidity after superficial parotidectomy: a prospective study concerning pain and resumption of normal activity. Clin Otolaryngol. 2007 Feb;32(1):54-7.
- Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.
- Ossiander EM. Using textual cause-of-death data to study drug poisoning deaths. Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 Feb 11.
- Sommer M, Geurts JW, Stessel B, Kessels AG, Peters ML, Patijn J, van Kleef M, Kremer B, Marcus MA. Prevalence and predictors of postoperative pain after ear, nose, and throat surgery. Arch Otolaryngol Head Neck Surg. 2009 Feb;135(2):124-30. doi: 10.1001/archoto.2009.3.
- Song CM, Ji YB, Bang HS, Kim KR, Kim H, Tae K. Postoperative Pain After Robotic Thyroidectomy by a Gasless Unilateral Axillo-Breast or Axillary Approach. Surg Laparosc Endosc Percutan Tech. 2015 Dec;25(6):478-82. doi: 10.1097/SLE.0000000000000204.
- van Dijk JF, Kappen TH, Schuurmans MJ, van Wijck AJ. The Relation Between Patients' NRS Pain Scores and Their Desire for Additional Opioids after Surgery. Pain Pract. 2015 Sep;15(7):604-9. doi: 10.1111/papr.12217. Epub 2014 Apr 16.
- van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. Postoperative pain assessment based on numeric ratings is not the same for patients and professionals: a cross-sectional study. Int J Nurs Stud. 2012 Jan;49(1):65-71. doi: 10.1016/j.ijnurstu.2011.07.009. Epub 2011 Aug 15.
Responsible Party:
Jared Inman,
Associate Professor,
Loma Linda University
ClinicalTrials.gov Identifier:
NCT03404518
Other Study ID Numbers:
- 5170252
First Posted:
Jan 19, 2018
Last Update Posted:
Mar 16, 2022
Last Verified:
Feb 1, 2022
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.:
Yes
Keywords provided by Jared Inman,
Associate Professor,
Loma Linda University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Arm/Group Description | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control |
| Period Title: Overall Study | ||
| STARTED | 97 | 88 |
| COMPLETED | 56 | 52 |
| NOT COMPLETED | 41 | 36 |
Baseline Characteristics
| Arm/Group Title | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Arm/Group Description | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control | Total of all reporting groups |
| Overall Participants | 56 | 52 | 108 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53
(17)
|
52.9
(17)
|
53
(17)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
37
66.1%
|
26
50%
|
63
58.3%
|
| Male |
19
33.9%
|
26
50%
|
45
41.7%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Prior Narcotic use (Count of Participants) | |||
| Count of Participants [Participants] |
4
7.1%
|
3
5.8%
|
7
6.5%
|
| Chronic Pain (Count of Participants) | |||
| Count of Participants [Participants] |
15
26.8%
|
11
21.2%
|
26
24.1%
|
| Surgery Length (minutes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [minutes] |
94.4
(43)
|
95.3
(43)
|
94.8
(42.7)
|
| Revision Surgery (Count of Participants) | |||
| Count of Participants [Participants] |
19
33.9%
|
16
30.8%
|
35
32.4%
|
Outcome Measures
| Title | Narcotic Usage |
|---|---|
| Description | The average number of narcotic pills needed or used for pain control |
| Time Frame | First 7 days after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Arm/Group Description | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control |
| Measure Participants | 56 | 52 |
| Mean (95% Confidence Interval) [Pills] |
4.9
|
2.0
|
| Title | Patient Pain Level |
|---|---|
| Description | The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain. |
| Time Frame | Average reported pain for first 7 days after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Arm/Group Description | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control |
| Measure Participants | 56 | 52 |
| Mean (95% Confidence Interval) [Scores on a scale] |
3.5
|
2.8
|
| Title | Ibuprofen Usage |
|---|---|
| Description | The average number of ibuprofen pills needed or used for pain control |
| Time Frame | First 7 days after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Norco and Ibuprofen | Ibuprofen and Norco |
|---|---|---|
| Arm/Group Description | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control |
| Measure Participants | 56 | 52 |
| Mean (95% Confidence Interval) [pills] |
4.5
|
7.7
|
Adverse Events
| Time Frame | Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery | |||
| Arm/Group Title | Norco and Ibuprofen | Ibuprofen and Norco | ||
| Arm/Group Description | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control | ||
All Cause Mortality |
||||
| Norco and Ibuprofen | Ibuprofen and Norco | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/97 (0%) | 0/88 (0%) | ||
Serious Adverse Events |
||||
| Norco and Ibuprofen | Ibuprofen and Norco | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/97 (0%) | 0/88 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Norco and Ibuprofen | Ibuprofen and Norco | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/97 (4.1%) | 3/88 (3.4%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 1/97 (1%) | 0/88 (0%) | ||
| Nervous system disorders | ||||
| Headache | 1/97 (1%) | 0/88 (0%) | ||
| Surgical and medical procedures | ||||
| Drainage from surgical site | 1/97 (1%) | 1/88 (1.1%) | ||
| Uncontrolled pain | 1/97 (1%) | 2/88 (2.3%) | ||
Limitations/Caveats
Some patients chose to not follow study instructions strictly and utilized ibuprofen therapy as primary analgesic treatment instead of their opioid medication.
More Information
Certain Agreements
All Principal Investigators ARE 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.
Results Point of Contact
| Name/Title | Khanh Nguyen, MD |
|---|---|
| Organization | Loma Linda University Health System |
| Phone | 909-558-8558 |
| khanguyen@llu.edu |
Responsible Party:
Jared Inman,
Associate Professor,
Loma Linda University
ClinicalTrials.gov Identifier:
NCT03404518
Other Study ID Numbers:
- 5170252
First Posted:
Jan 19, 2018
Last Update Posted:
Mar 16, 2022
Last Verified:
Feb 1, 2022