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

NCT00793910 | Completed Results

• 1 other identifier: WRAMC WU# 08-6960
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Gabapentin; PRK; pain

Outcome Measures

Primary Outcomes (4)

• Level of Pain

  level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  2 hours postoperatively

• Level of Pain

  level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  day 1 postoperatively

• Level of Pain

  level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  3 days postoperatively

• Level of Pain

  level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)

  4 days postoperatively

Secondary Outcomes (1)

• Occurence of Use of Rescue Medication

  2 hours to 4 days postoperatively

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

oral medication

Drug: Gabapentin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Gabapentin DRUG

Gabapentin 300 mg taken by mouth thrice daily for 7 days

Gabapentin

placebo DRUG

placebo (sugar pill) taken by mouth thrice daily for 7 days

placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Matthew Kuhnle, DO
• Organization: Carl R. Darnall Army Medical Center

matthew.kuhnle@us.army.mil

216-965-3518

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 16, 2014
• Results First Posted: February 7, 2012

Record last verified: 2014-07

Locations

US (1)