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

This study has been completed.

First Received: November 18, 2008 Last Updated: June 5, 2009 History of Changes

Sponsor:	Walter Reed Army Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00793910

Purpose

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.

Condition	Intervention
Postoperative Pain	Drug: Gabapentin Drug: placebo

Study Type:	Interventional
Study Design:	Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title:	Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-Masked, Single Center, Placebo-Controlled Clinical Trial

Resource links provided by NLM:

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

The primary outcome measure will be level of pain as assessed using the visual analog scale of pain.

Secondary Outcome Measures:

Secondary outcome measures will be the frequency of use of rescue medications to include usage of topical ketorolac and an oral narcotic.

Study Start Date:

July 2008

Arms	Assigned Interventions
Gabapentin: Active Comparator oral medication	Drug: Gabapentin
placebo: Placebo Comparator	Drug: placebo oral medication

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793910

Locations

United States, District of Columbia
Wa;ter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed Army Medical Center

More Information

No publications provided

Study ID Numbers:	WRAMC WU# 08-6960
Study First Received:	November 18, 2008
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00793910 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

Gabapentin
PRK
pain

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Pain
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes
Sensory System Agents

Therapeutic Uses
Analgesics
Pain, Postoperative
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Postoperative Complications
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010