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

This study has been completed.

Study NCT00793910 Information provided by Walter Reed Army Medical Center

First Received on November 18, 2008. Last Updated on January 4, 2012 History of Changes

Results First Received: November 21, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Postoperative Pain
Interventions:	Drug: Gabapentin Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Gabapentin	Gabapentin 300mg taken by mouth thrice daily for 7 days
Placebo	placebo (sugar pill) taken by mouth thrice daily for 7 days

Participant Flow: Overall Study

	Gabapentin	Placebo
STARTED	53	53
COMPLETED	48	46
NOT COMPLETED	5	7
discarded study pills	0	1
did not pick up medications	1	1
ineligible based on entry criteria	2	3
decided to undergo LASIK instead of PRK	2	1
Withdrawal by Subject	0	1

Baseline Characteristics

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Reporting Groups

	Description
Gabapentin	Gabapentin 300mg taken by mouth thrice daily for 7 days
Placebo	placebo (sugar pill) taken by mouth thrice daily for 7 days

Baseline Measures

	Gabapentin	Placebo	Total
Number of Participants [units: participants]	48	46	94
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	48	46	94
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	30.7 ± 8	33.2 ± 7.9	31.9 ± 8
Gender [units: participants]
Female	6	7	13
Male	42	39	81
Region of Enrollment [units: participants]
United States	48	46	94

Outcome Measures

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1. Primary:

Level of Pain [ Time Frame: 2 hours postoperatively ]

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2. Primary:

Level of Pain [ Time Frame: day 1 postoperatively ]

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3. Primary:

Level of Pain [ Time Frame: 3 days postoperatively ]

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4. Primary:

Level of Pain [ Time Frame: 4 days postoperatively ]

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5. Secondary:

Frequency of Use of Rescue Medications to Include Usage of Topical Ketorolac and an Oral Narcotic. [ Time Frame: 2 hours to 4 days postoperatively ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All materials that reflects the WRAMC affiliation must be approved and properly cleared before the material is submitted for public dissemination and publication. All publications whereby WRAMC is cited in the bylines will state on the cover page the following sample disclaimer: “The views expressed in this [article, book chapter, speech, presentation, etc.] are those of the author(s) and do not reflect the official policy of the Department of Army, Department of Defense, or U.S. Government.”

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Matthew Kuhnle, DO
Organization: Carl R. Darnall Army Medical Center
phone: 216-965-3518
e-mail: matthew.kuhnle@us.army.mil

No publications provided

ClinicalTrials.gov Identifier:	NCT00793910 History of Changes
Other Study ID Numbers:	WRAMC WU# 08-6960
Study First Received:	November 18, 2008
Results First Received:	November 21, 2011
Last Updated:	January 4, 2012
Health Authority:	United States: Federal Government