Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: placebo; Drug: Gabapentin

• Registration Number: NCT00793910
• Lead Sponsor: Walter Reed Army Medical Center

Brief Summary

The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2011-11-21
• Results First Submitted QC: 2012-01-04
• Results First Posted: 2012-02-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
• Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
• Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
• Access to transportation to meet follow-up requirements.

Exclusion Criteria

• Any reason to be excluded for PRK.
• Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
• Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
• Patients with known depressed renal function.
• Any physical or mental impairment that would preclude participation in any of the examinations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Gabapentin	Gabapentin	oral medication

Primary Outcome Measures

Name	Time	Method
Level of Pain	4 days postoperatively	level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Occurence of Use of Rescue Medication	2 hours to 4 days postoperatively	Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States