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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793910
First Posted: November 19, 2008
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samantha B. Rodgers, MD, Fort Belvoir Community Hospital
  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: Triple (Participant, Care Provider, 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:


Further study details as provided by Samantha B. Rodgers, MD, Fort Belvoir Community Hospital:

Primary Outcome Measures:
  • Level of Pain [ Time Frame: 2 hours postoperatively ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Samantha B. Rodgers, MD, Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT00793910     History of Changes
Other Study ID Numbers: WRAMC WU# 08-6960
First Submitted: November 18, 2008
First Posted: November 19, 2008
Results First Submitted: November 21, 2011
Results First Posted: February 7, 2012
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Samantha B. Rodgers, MD, Fort Belvoir Community Hospital:
Gabapentin
PRK
pain

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