The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.

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Detailed Description

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Conditions

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Pain After Photorefractive Keratectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GABAPENTIN

Group of patients treated with oral gabapentin

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.

PLACEBO

Group given the placebo capsules

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.

Interventions

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Gabapentin

Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.

Intervention Type DRUG

Sugar pill

Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be at least 18 years of age
2. Subjects must not have any corneal disease or degeneration
3. Subjects must be candidates for LASIK or PRK refractive surgery

Exclusion Criteria

1. History of topical ocular medications within 4 weeks prior to enrollment
2. History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
3. History of a previous refractive surgery
4. History of previous diagnosis of corneal disease, degeneration, or glaucoma
5. History of autoimmune disease
6. History of oral anti-histamines currently or within 1 week of study enrollment
7. History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment
8. Use of oral diuretics or betablocker currently or within 1 week of study enrollment
9. Current diagnosis of dry eye
10. Patients whose Best corrected vision is less than 20/20
11. Patients whose target post operative refraction is not plano
12. Pregnant and lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No