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

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00793910
First received: November 18, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Level of Pain [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: No ]
    level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  • Level of Pain [ Time Frame: day 1 postoperatively ] [ Designated as safety issue: No ]
    level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  • Level of Pain [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
    level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  • Level of Pain [ Time Frame: 4 days postoperatively ] [ Designated as safety issue: No ]
    level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)


Secondary Outcome Measures:
  • Occurence of Use of Rescue Medication [ Time Frame: 2 hours to 4 days postoperatively ] [ Designated as safety issue: No ]
    Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured


Enrollment: 106
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin
oral medication
 Drug: Gabapentin
Gabapentin 300 mg taken by mouth thrice daily for 7 days
Placebo Comparator: placebo Drug: placebo
placebo (sugar pill) taken by mouth thrice daily for 7 days

  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
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00793910     History of Changes
Other Study ID Numbers: WRAMC WU# 08-6960
Study First Received: November 18, 2008
Results First Received: November 21, 2011
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Gabapentin
PRK
pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 23, 2013