Status:
COMPLETED
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
Lead Sponsor:
Walter Reed Army Medical Center
Conditions:
Postoperative Pain
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00793910
Start Date
July 1 2008
End Date
July 1 2009
Last Update
July 16 2014
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307