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NCT00954187 · ClinicalTrials.gov registry record · NA
Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy
A NA study, sponsored by Loma Linda University.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT00954187 is a NA study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 8 participants.
The verdict
NCT00954187, a NA study, was terminated before completion, sponsored by Loma Linda University.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK). Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK. Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented. Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.
Interventions
- DRUG Gabapentin
- DRUG pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00954187
The ClinicalTrials.gov registry entry for NCT00954187 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gabapentin is the first listed.
NCT00954187 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00954187 about?
NCT00954187 is a clinical study titled "Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy". Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK). Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two t...
What is the current status of trial NCT00954187?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2009-11. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00954187?
The interventions under investigation include: Gabapentin (DRUG), pregabalin (DRUG).
Who is sponsoring clinical trial NCT00954187?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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