Phase 4
N=200
Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
Post-operative Pain Control
Bottom Line
View on ClinicalTrials.gov: NCT04399122 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Post-operative Average Pain Score — 2.82; 3.58 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- acetaminophen/codeine vs acetaminophen/oxycodone (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- 59th Medical Wing
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Average Pain Score |
2.82; 3.58 | — |
| SECONDARY Post-operative Uncorrected Visual Acuity Right and Left Eye |
-0.07; -0.05; -0.06; -0.06 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04399122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.