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Completed

NCT Number: NCT00793910

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed Army Medical Center

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Gabapentin 300 mg taken by mouth thrice daily for 7 days

Placebo

Drug

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

Primary outcomes

  1. Level of Pain

    Time frame: 2 hours postoperatively

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

  2. Level of Pain

    Time frame: day 1 postoperatively

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

  3. Level of Pain

    Time frame: 3 days postoperatively

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

  4. Level of Pain

    Time frame: 4 days postoperatively

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

Secondary outcomes

  1. Occurence of Use of Rescue Medication

    Time frame: 2 hours to 4 days postoperatively

    Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured

Sponsors and collaborators

Lead sponsor

Walter Reed Army Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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