An interventional study of Gabapentin and placebo in Postoperative Pain, sponsored by Walter Reed Army Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-16.
Sponsored by Walter Reed Army Medical Center · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 106 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Walter Reed Army Medical Center is the lead sponsor of 45 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
oral medication
Drug: Gabapentin
Drug: placebo
Gabapentin 300 mg taken by mouth thrice daily for 7 days
placebo (sugar pill) taken by mouth thrice daily for 7 days
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 4 days postoperatively
Occurence of Use of Rescue Medication
Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured
Time frame: 2 hours to 4 days postoperatively
| Milestone | Gabapentin | Placebo |
|---|---|---|
| Started | 53 | 53 |
| Completed | 48 | 46 |
| Not completed | 5 | 7 |
| Withdrew: Discarded study pills | 0 | 1 |
| Withdrew: Did not pick up medications | 1 | 1 |
| Withdrew: Ineligible based on entry criteria | 2 | 3 |
| Withdrew: Decided to undergo lasik instead of prk | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Level of Pain | 3.85 ± 2.05 | 4.09 ± 2.38 |
Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured
| # of times rescue meds were used | Gabapentin | Placebo |
|---|---|---|
| Occurence of Use of Rescue Medication | 7.54 ± 3.45 | 7.15 ± 3.9 |
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Level of Pain | 3.00 ± 2.01 | 4.00 ± 1.97 |
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Level of Pain | 2.09 ± 1.57 | 2.58 ± 2.08 |
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Level of Pain | 1.30 ± 1.16 | 1.86 ± 1.96 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | — | 0/53 (0%) | 0/53 (0%) |
| Placebo | — | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 46 | 94 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Mean | 30.7 ± 8 | 33.2 ± 7.9 | 31.9 ± 8 |
| Sex: Female, Male(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 42 | 39 | 81 |
| Region of Enrollment(participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| United States | 48 | 46 | 94 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Walter Reed Army Medical Center