Conditions: Postoperative Pain
Keywords: photorefractive keratectomy excimer laser PRK pain, postoperative pregabalin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

Detailed description:
Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD (Department of Defense) beneficiaries. Prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular status.

Patients scheduled for PRK surgery will be briefed on the purpose of the study and invited to participate at the preoperative appointment. After the consent process, patients will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg twice daily or placebo for pain control, in addition to the standard care treatment of as needed Percocet and tetracaine ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective pain assessment, adverse drug events and compliance, use of concomitant medications as well as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2 when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10% improvement in pain scores. Secondary outcomes will include measuring healing time, quality of life and use of rescue medications.

Arms:
arm 1: Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days arm 2: Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days

Interventions: intervention 1: pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively. intervention 2: 1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.

Protocol document: