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

NCT ID: NCT00793910

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-07-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gabapentin

oral medication

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

Gabapentin 300 mg taken by mouth thrice daily for 7 days

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo (sugar pill) taken by mouth thrice daily for 7 days

Interventions

Gabapentin

Gabapentin 300 mg taken by mouth thrice daily for 7 days

Intervention Type: DRUG

placebo

placebo (sugar pill) taken by mouth thrice daily for 7 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Samantha B. Rodgers, MD

Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

WRAMC WU# 08-6960

Identifier Type: -

Identifier Source: org_study_id