Title
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial
Phase
N/ALead Sponsor
United States ArmyStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Postoperative PainIntervention/Treatment
gabapentin ...Study Participants
106The 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.
Gabapentin 300 mg taken by mouth thrice daily for 7 days
placebo (sugar pill) taken by mouth thrice daily for 7 days
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.
| Event Type | Organ System | Event Term |
|---|
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured
