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Phase 4 N=200 Randomized Double-blind Supportive Care

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

Post-operative Pain Control

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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