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Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy

Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Recruiting Postoperative Pain Loma Linda University Other August 5, 2009 March 27, 2012 March 2012

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment N/A 104 November 2009 -


Loma Linda University - Ophthalmology Loma Linda California 92354 United States Blen Eshete, MPH(c) - Recruiting


Drug Gabapentin Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days
Drug pregabalin 50 mg PO TID


TypeMeasureTime FrameSafety Issue
Primary Decreased overall pain score as measured by the visual analogue scale one month No

Official Title

Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study.



One hundred and four patients who meet the inclusion criteria undergoing photorefractive
keratectomy (PRK) in one or both eyes will be randomly assigned into one of two treatment
groups via computer. 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. Patients in the gabapentin group will take
300 mg three times a day starting two hours prior to surgery and will continue for a total
of four days. Patients in the pregabalin group will take 50 mg three times a day starting
two hours prior to surgery and will also continue for four days.

Only the refractive surgery coordinator and the patient will know what medication the
patient is taking. The patient will be instructed not to share this information with any
other study participants or their surgeon. The coordinator will keep a list of the patients
ID numbers and the treatments they are receiving.

Prior to surgery, each patient will be taught how to assess their pain level using the
visual analogue scale (VAS), a well documented method of pain assessment. After
surgery the patients will assess their pain levels at different intervals of time - one hour
after surgery, the evening of the surgery, and three times a day for four subsequent days.
Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale
(ESS) and record the presence of dizziness daily for the same amount of time. On the fourth
day they will return to clinic for a post operative appointment. At that time the pain
assessment scales will be collected and analyzed. The patients will return at one month to
further assess long term pain after PRK.

Statistical Analysis:

Postoperative pain levels recorded using the visual analogue scales, ESS, and self reported
dizziness assessments will be collected on the fourth postoperative day. These will be
compiled into data sets and analyzed. Data will be compiled into means with lower and upper
quartiles and analyzed using a two-sided t test. The difference in pain levels will be
described throughout the postoperative period to determine if one medication significantly
reduces postoperative pain initially within the first 24 hours, during the interval between
24 hours to four days, and further after surgery (one month postoperatively). Data regarding
levels of somnolence and dizziness will also be reported.


GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - 70 Years Accepts Healthy Volunteers

Inclusion Criteria:

- 18 years of age or older

- Undergoing PRK in at least one eye

Exclusion Criteria:

- Serious medical problems within the last 6 months including myocardial infarction
(heart attack), congestive heart failure, stroke, deep vein thrombosis, pulmonary
embolism, and other conditions, etc.

- Serious kidney disease as evidenced by the need for dialysis or kidney transplant.

- History of seizure or other neurologic disorders.

- Patients intending to become pregnant or who are pregnant or nursing over the
projected course of treatment.

- Currently taking gabapentin or pregabalin for other medical purposes.

- Known allergic reaction to gabapentin or pregabalin from previous use.

- Plans to move out of the area within 8 weeks after the surgery.


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