Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
Information source: Walter Reed Army Medical Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Gabapentin (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Walter Reed Army Medical Center Overall contact:
Matthew Kuhnle, DO, Phone: 202-782-6965, Email: matthew.kuhnle@amedd.army.mil
Summary
The purpose of this study is to determine the effectiveness of an oral medication called
gabapentin in reducing pain after 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.
Clinical Details
Official title: Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-Masked, Single Center, Placebo-Controlled Clinical Trial
Study design: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary outcome: The primary outcome measure will be level of pain as assessed using the visual analog scale of pain.
Secondary outcome: Secondary outcome measures will be the frequency of use of rescue medications to include usage of topical ketorolac and an oral narcotic.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Matthew Kuhnle, DO, Phone: 202-782-6965, Email: matthew.kuhnle@amedd.army.mil
Wa;ter Reed Army Medical Center, Washington, District of Columbia 20307, United States; Recruiting
Matthew Kuhnle, DO, Phone: 202-782-6965, Email: matthew.kuhnle@amedd.army.mil
Additional Information
Starting date: July 2008
Last updated: November 18, 2008
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