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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
placebo
Sponsored by
Walter Reed Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Gabapentin, PRK, pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin

placebo

Arm Description

oral medication

Outcomes

Primary Outcome Measures

Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Level of Pain
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
Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured

Full Information

First Posted
November 18, 2008
Last Updated
July 10, 2014
Sponsor
Walter Reed Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00793910
Brief Title
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed Army Medical Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Gabapentin, PRK, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
oral medication
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 300 mg taken by mouth thrice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo (sugar pill) taken by mouth thrice daily for 7 days
Primary Outcome Measure Information:
Title
Level of Pain
Description
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Time Frame
2 hours postoperatively
Title
Level of Pain
Description
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Time Frame
day 1 postoperatively
Title
Level of Pain
Description
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Time Frame
3 days postoperatively
Title
Level of Pain
Description
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Time Frame
4 days postoperatively
Secondary Outcome Measure Information:
Title
Occurence of Use of Rescue Medication
Description
Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured
Time Frame
2 hours to 4 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

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

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