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

NCT04399122 | Completed Phase 4 Results FDA Drug

• 1 other identifier: FWH20160007H
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain Control

Keywords

Photorefractive Keratectomy; Post-operative Eye Pain; Refractive Surgery

Outcome Measures

Primary Outcomes (1)

• Post-operative Average Pain Score

  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

  2 days post surgery

Secondary Outcomes (1)

• Post-operative Uncorrected Visual Acuity Right and Left Eye

  Post-operative month 6.

Study Arms (2)

Acetaminophen with codeine

ACTIVE COMPARATOR

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

Acetaminophen with oxycodone

ACTIVE COMPARATOR

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

Interventions

acetaminophen/codeine vs acetaminophen/oxycodone DRUG

pain medications

Also known as: Tylenol 3 VS Percocet

Acetaminophen with codeine; Acetaminophen with oxycodone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 59th Medical Wing: lead

Study Sites (1)

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, 78236, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Jose E. Capo-Aponte
• Organization: Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Jose.E.CapoAponte.ctr@mail.mil

(210) 292-2554

Study Officials

• Charisma B Evangelista, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization was accomplished by the pharmacy and the medication bottles were not labeled.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Refractive Surgery

Model Details: Patients will be randomized to Group 1 or Group 2

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: March 21, 2017
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: October 5, 2021
• Results First Posted: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)