Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
Completed · Not applicable · Has a placebo group
Conditions studied: Postoperative Pain
In brief
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.
Key facts
- Study ID
- NCT00793910
- Run by
- Walter Reed Army Medical Center
- People needed
- 106
- Starts
- 2008-07-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2014-07-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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