Trial Outcomes & Findings for Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone (NCT NCT04399122)

Last Updated: 2021-10-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

2 days post surgery

Results posted on

2021-10-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	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. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications
Overall Study STARTED	100	100
Overall Study COMPLETED	97	100
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications	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. acetaminophen/codeine vs acetaminophen/oxycodone: pain medications
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen With Codeine n=97 Participants 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	Acetaminophen With Oxycodone n=100 Participants 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 n=197 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=97 Participants	0 Participants n=100 Participants	0 Participants n=197 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=97 Participants	100 Participants n=100 Participants	197 Participants n=197 Participants
Age, Categorical >=65 years	0 Participants n=97 Participants	0 Participants n=100 Participants	0 Participants n=197 Participants
Age, Continuous	33.5 years STANDARD_DEVIATION 7.5 • n=97 Participants	31.5 years STANDARD_DEVIATION 6.5 • n=100 Participants	32.5 years STANDARD_DEVIATION 6.7 • n=197 Participants
Sex: Female, Male Female	81 Participants n=97 Participants	73 Participants n=100 Participants	154 Participants n=197 Participants
Sex: Female, Male Male	16 Participants n=97 Participants	27 Participants n=100 Participants	43 Participants n=197 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	97 Participants n=97 Participants	100 Participants n=100 Participants	197 Participants n=197 Participants

PRIMARY outcome

Timeframe: 2 days post surgery

Outcome measures

Outcome measures
Measure	Acetaminophen With Codeine n=97 Participants 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	Acetaminophen With Oxycodone n=100 Participants 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
Post-operative Average Pain Score	2.82 units on a scale Standard Deviation 2.03	3.58 units on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Post-operative month 6.

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

Outcome measures

Outcome measures
Measure	Acetaminophen With Codeine n=97 Participants 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	Acetaminophen With Oxycodone n=100 Participants 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
Post-operative Uncorrected Visual Acuity Right and Left Eye Left Eye logMAR	-0.06 logMAR Standard Deviation 0.01	-0.06 logMAR Standard Deviation 0.01
Post-operative Uncorrected Visual Acuity Right and Left Eye Right Eye logMAR	-0.07 logMAR Standard Deviation 0.01	-0.05 logMAR Standard Deviation 0.01

Adverse Events

Acetaminophen With Codeine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen With Oxycodone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jose E. Capo-Aponte

Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Phone: (210) 292-2554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place