Trial Outcomes & Findings for Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy (NCT NCT00793910)

NCT ID: NCT00793910

Last Updated: 2014-07-16

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 106 participants
• Primary outcome timeframe: 2 hours postoperatively
• Results posted on: 2014-07-16

Participant Flow

Participant milestones

Measure	Gabapentin Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo placebo (sugar pill) taken by mouth thrice daily for 7 days
Overall Study STARTED	53	53
Overall Study COMPLETED	48	46
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Gabapentin Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo placebo (sugar pill) taken by mouth thrice daily for 7 days
Overall Study discarded study pills	0	1
Overall Study did not pick up medications	1	1
Overall Study ineligible based on entry criteria	2	3
Overall Study decided to undergo LASIK instead of PRK	2	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Gabapentin n=48 Participants Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo n=46 Participants placebo (sugar pill) taken by mouth thrice daily for 7 days	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.7 years STANDARD_DEVIATION 8 • n=5 Participants	33.2 years STANDARD_DEVIATION 7.9 • n=7 Participants	31.9 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	46 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours postoperatively

Population: 11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake

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

Outcome measures

Measure	Gabapentin n=41 Participants Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo n=41 Participants placebo (sugar pill) taken by mouth thrice daily for 7 days
Level of Pain	3.85 units on a scale Standard Deviation 2.05	4.09 units on a scale Standard Deviation 2.38

PRIMARY outcome

Timeframe: day 1 postoperatively

Population: 11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake

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

Outcome measures

Measure	Gabapentin n=41 Participants Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo n=41 Participants placebo (sugar pill) taken by mouth thrice daily for 7 days
Level of Pain	3.00 units on a scale Standard Deviation 2.01	4.00 units on a scale Standard Deviation 1.97

PRIMARY outcome

Timeframe: 3 days postoperatively

Population: 11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake

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

Outcome measures

Measure	Gabapentin n=41 Participants Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo n=41 Participants placebo (sugar pill) taken by mouth thrice daily for 7 days
Level of Pain	2.09 units on a scale Standard Deviation 1.57	2.58 units on a scale Standard Deviation 2.08

PRIMARY outcome

Timeframe: 4 days postoperatively

Population: 11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake

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

Outcome measures

Measure	Gabapentin n=41 Participants Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo n=41 Participants placebo (sugar pill) taken by mouth thrice daily for 7 days
Level of Pain	1.30 units on a scale Standard Deviation 1.16	1.86 units on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: 2 hours to 4 days postoperatively

Population: 11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake

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

Outcome measures

Measure	Gabapentin n=41 Participants Gabapentin 300mg taken by mouth thrice daily for 7 days	Placebo n=41 Participants placebo (sugar pill) taken by mouth thrice daily for 7 days
Occurence of Use of Rescue Medication	7.54 # of times rescue meds were used Standard Deviation 3.45	7.15 # of times rescue meds were used Standard Deviation 3.9

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Kuhnle, DO

Carl R. Darnall Army Medical Center

Phone: 216-965-3518

Email: matthew.kuhnle@us.army.mil

Results disclosure agreements

• Principal investigator is a sponsor employee 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."
• Publication restrictions are in place

Restriction type: OTHER