Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone

• Sponsor: 59th Medical Wing (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT04399122
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.2
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

Photorefractive keratectomy (PRK) is a refractive error correction procedure that helps eliminate or reduce the dependence on corrective lenses. An important aspect of PRK is post-operative pain management. Post-operative pain can be significant in the first three to five days and is typically controlled utilizing various modalities including narcotic pain medication. Simple observation suggests a difference in the post-operative pain levels of patients utilizing the more potent oxycodone- versus the less potent codeine-containing acetaminophen preparations. There have been no studies performed to explore any differences in perceived pain comparing these two medications when used following PRK. This study is designed to answer this question by means of a pain survey conducted in the first five days post-op. This may help better manage similar patients in the future.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain Control	Drug: acetaminophen/codeine vs acetaminophen/oxycodone	Phase 4

Detailed Description

This will be a prospective pain assessment study utilizing a simple three question survey given to patients undergoing bilateral PRK. Following recruitment and enrollment (see section 4.1 and 4.2 for recruitment and consent process), patients will be randomized to be prescribed either 1) Group 1: codeine 30mg/acetaminophen 300mg (standard of care dosage) or 2) Group 2: oxycodone 5mg/acetaminophen 325mg (standard of care dosage) post-operatively. All post-operative patients will receive standard bandage contact lenses and as needed tetracaine as per standard of care. Patients will be removed from the study if they take other non-study pain medications. They will be asked to record their pain levels four times daily as well as the number of as needed narcotic pain medication taken and the number of tetracaine drops used (to isolate a potential confounding pain control modality). Randomization will be performed with the aid of www.randomizer.org which will generate a randomized assignment to either group 1 or group 2.

All PRK procedures will be performed per standard of care. The procedure will be performed by one of the 4 approved surgeons. All surgeons will use the same technique using either the VISX or the Allegretto laser machines. This technique will include use of a brush for mechanical removal of corneal epithelial cells. The surgeons will take note at this time of the relative adherence of the epithelium to the underlying tissue and grade the adherence on a scale of 0-4 (0=least adherent and 4=most adherent). In the data analysis, differences between surgeons and between operating platform (VISX vs Allegretto) will be compared to account for any possible bias in operating parameters.

The survey will be worded as follows:

1. "Rate your eye pain or level of discomfort at 0800, 1200, 1600 and 2000. Please write the number closest to your response in the table below under the appropriate day and time.

2. "How many tablets of study-related pain medication did you take today in the AM/PM?"

3. "How many times did you use topical tetracaine today in the AM/PM?"

4. "Did you take any other non-study related pain medications?"

Patients will be followed-up post-operatively as per standard of care. This includes follow-up visits at 1 day, 1 week, 1 month, 3 months, 6 months and 12 months. Starting on post-operative day 1, the patients will be asked to record their pain levels using the pain survey at four hour intervals (0800, 1200, 1600, 2000). At the 1 week post-operative visit, the pain surveys will be collected from the patients. Visual acuity data will be extracted from all but the 12 month follow-up appointment and used as a secondary outcome to correlate any possible differences in pain scores to functional outcomes in terms of visual acuity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomized to Group 1 or Group 2Patients will be randomized to Group 1 or Group 2
• Masking: Double (Participant, Investigator)
• Masking Description: Randomization was accomplished by the pharmacy and the medication bottles were not labeled.
• Primary Purpose: Supportive Care
• Official Title: Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
• Actual Study Start Date: Mar 21, 2017
• Actual Primary Completion Date: Oct 28, 2019
• Actual Study Completion Date: Oct 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acetaminophen with codeine codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery.	Drug: acetaminophen/codeine vs acetaminophen/oxycodone; pain medications; Other Names: Tylenol 3 VS Percocet
Active Comparator: Acetaminophen with oxycodone oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery.	Drug: acetaminophen/codeine vs acetaminophen/oxycodone; pain medications; Other Names: Tylenol 3 VS Percocet

Outcome Measures

Primary Outcome Measures

1. Post-operative Average Pain Score [2 days post surgery]

   The PRK Post-Operative Pain Survey consisted of a scale of 0 - 10 with a score of 0 equal to no pain, a score of 1 - 3 equal to mild pain, a score of 4 - 6 equal to moderate pain and a score of 7 - 10 equal to severe pain

Secondary Outcome Measures

1. Post-operative Uncorrected Visual Acuity Right and Left Eye [Post-operative month 6.]

   Right and left eye uncorrected visual acuity at post-operative month 6.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• M/F >21 years of age (PRK is not done on anyone under the age of 21 at this surgery center)

• Have met all criteria for bilateral PRK

Exclusion Criteria

• Patients who do not meet the criteria for refractive surgery

• Patients receiving LASIK

• Patients known to have an allergy to either of the study pain medications

• Patients receiving refractive surgery on only one eye

• Pregnant women, children, military basic trainees, prisoners and detainees

• Subject has used narcotics in the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joint Warfighter Refractive Surgery Center at WHASC	San Antonio	Texas	United States	78236

Sponsors and Collaborators

• 59th Medical Wing

Investigators

• Principal Investigator: Charisma B Evangelista, MD, 59th Medical Wing

Study Documents (Full-Text)

• Study Protocol - Sep 6, 2017

More Information

Publications

None provided.

• Responsible Party: Charisma Evangelista, Chief of Refractive Surgery, 59th Medical Wing
• ClinicalTrials.gov Identifier: NCT04399122
• Other Study ID Numbers: FWH20160007H
• First Posted: May 22, 2020
• Last Update Posted: Oct 5, 2021
• Last Verified: Sep 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
• Keywords provided by Charisma Evangelista, Chief of Refractive Surgery, 59th Medical Wing: Photorefractive Keratectomy; Post-operative Eye Pain; Refractive Surgery
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Codeine

Study Results

Participant Flow

Recruitment Details	In this single-center, double-masked randomized clinical trial, patients were recruited at the Joint Warfighter Refractive Surgery Center (JWRSC) at Wilford Hall Ambulatory Surgical Center, Lackland Air Force Base, Texas, between March 2016 and April 2019.

Arm/Group Title	Acetaminophen With Codeine	Acetaminophen With Oxycodone
Arm/Group Description	codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications
Period Title: Overall Study
STARTED	100	100
COMPLETED	97	100
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Acetaminophen With Codeine	Acetaminophen With Oxycodone	Total
Arm/Group Description	codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	Total of all reporting groups
Overall Participants	97	100	197
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	97 100%	100 100%	197 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.5 (7.5)	31.5 (6.5)	32.5 (6.7)
Sex: Female, Male (Count of Participants)
Female	81 83.5%	73 73%	154 78.2%
Male	16 16.5%	27 27%	43 21.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	97 100%	100 100%	197 100%

Outcome Measures

1. Primary Outcome

Title	Post-operative Average Pain Score
Description	The PRK Post-Operative Pain Survey consisted of a scale of 0 - 10 with a score of 0 equal to no pain, a score of 1 - 3 equal to mild pain, a score of 4 - 6 equal to moderate pain and a score of 7 - 10 equal to severe pain
Time Frame	2 days post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen With Codeine	Acetaminophen With Oxycodone
Arm/Group Description	codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications
Measure Participants	97	100
Mean (Standard Deviation) [units on a scale]	2.82 (2.03)	3.58 (2.29)

2. Secondary Outcome

Title	Post-operative Uncorrected Visual Acuity Right and Left Eye
Description	Right and left eye uncorrected visual acuity at post-operative month 6.
Time Frame	Post-operative month 6.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen With Codeine	Acetaminophen With Oxycodone
Arm/Group Description	codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications
Measure Participants	97	100
Right Eye logMAR	-0.07 (0.01)	-0.05 (0.01)
Left Eye logMAR	-0.06 (0.01)	-0.06 (0.01)

Adverse Events

Time Frame	1 year
Arm/Group Title	Acetaminophen With Codeine		Acetaminophen With Oxycodone
Arm/Group Description	codeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications		oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications
All Cause Mortality
	Acetaminophen With Codeine		Acetaminophen With Oxycodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/100 (0%)
Serious Adverse Events
	Acetaminophen With Codeine		Acetaminophen With Oxycodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Acetaminophen With Codeine		Acetaminophen With Oxycodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

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.