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

Postoperative Pain Clinical Trial

Official title:

Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793910
• Other study ID #: WRAMC WU# 08-6960
• Status: Completed
• Phase: N/A
• First received: November 18, 2008
• Last updated: July 10, 2014
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2014
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Gabapentin
Gabapentin 300 mg taken by mouth thrice daily for 7 days
• placebo
placebo (sugar pill) taken by mouth thrice daily for 7 days

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Occurence of Use of Rescue Medication	Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured	2 hours to 4 days postoperatively	No