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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samantha B. Rodgers, MD, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier:
NCT00793910
First received: November 18, 2008
Last updated: July 10, 2014
Last verified: July 2014

November 18, 2008
July 10, 2014
July 2008
July 2009   (final data collection date for primary outcome measure)
  • 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)
The primary outcome measure will be level of pain as assessed using the visual analog scale of pain.
Complete list of historical versions of study NCT00793910 on ClinicalTrials.gov Archive Site
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
Secondary outcome measures will be the frequency of use of rescue medications to include usage of topical ketorolac and an oral narcotic.
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: Gabapentin
    Gabapentin 300 mg taken by mouth thrice daily for 7 days
  • Drug: placebo
    placebo (sugar pill) taken by mouth thrice daily for 7 days
  • Active Comparator: Gabapentin
    oral medication
    Intervention: Drug: Gabapentin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793910
WRAMC WU# 08-6960
Not Provided
Samantha B. Rodgers, MD, Fort Belvoir Community Hospital
Walter Reed Army Medical Center
Not Provided
Not Provided
Walter Reed Army Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP