drugset / Trial / NCT00954187

Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy

NCT00954187

Terminated 8 enrolled Loma Linda University
RandomizedParallel-groupDouble-blindTreatment

Summary

Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK). Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK. Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented. Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.

Timeline

Start
2009-11
Primary completion
2012-09
Completion
2013-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Small molecule 300 mg Oral
Subject Pregabalin Small molecule 50 mg Oral

Indications

No indication recorded.