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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | oral medication |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 300 mg taken by mouth thrice daily for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin 300mg taken by mouth thrice daily for 7 days |
| FG001 | Placebo | placebo (sugar pill) taken by mouth thrice daily for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin 300mg taken by mouth thrice daily for 7 days |
| BG001 | Placebo | placebo (sugar pill) taken by mouth thrice daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Level of Pain | level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) | 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 | Posted | Mean | Standard Deviation | units on a scale | 2 hours postoperatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | Gabapentin 300mg taken by mouth thrice daily for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Kuhnle, DO | Carl R. Darnall Army Medical Center | 216-965-3518 | matthew.kuhnle@us.army.mil |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| placebo |
| Drug |
placebo (sugar pill) taken by mouth thrice daily for 7 days |
|
| ineligible based on entry criteria |
|
| decided to undergo LASIK instead of PRK |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Occurence of Use of Rescue Medication | Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured | 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 | Posted | Mean | Standard Deviation | # of times rescue meds were used | 2 hours to 4 days postoperatively |
|
|
|
| Primary | Level of Pain | level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) | 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 | Posted | Mean | Standard Deviation | units on a scale | day 1 postoperatively |
|
|
|
| Primary | Level of Pain | level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) | 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 | Posted | Mean | Standard Deviation | units on a scale | 3 days postoperatively |
|
|
|
| Primary | Level of Pain | level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) | 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 | Posted | Mean | Standard Deviation | units on a scale | 4 days postoperatively |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Placebo | placebo (sugar pill) taken by mouth thrice daily for 7 days | 0 | 53 | 0 | 53 |
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| D012816 | Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |