A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
NCT ID: NCT01097577
Last Updated: 2020-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2010-03-31
2010-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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pregabalin
Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days
pregabalin
1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
Placebo
Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days
Placebo
1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
Interventions
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pregabalin
1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
Placebo
1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable preoperative refractive anisometropia
* Consented to the PRK surgical procedure
Exclusion Criteria
* Diagnosed with autoimmune disease or diabetes
* Patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin
* Patients only desiring PRK on one eye
* Patients with history of drug use/abuse/addiction
* Patients who are on chronic pain medications
* Patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications
* Patients with a history of suicidality
* Patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or Scr ≥ 2.0) 10) Patients who have experienced angioedema, or have heart failure
21 Years
ALL
No
Sponsors
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59th Medical Wing
FED
Responsible Party
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Julie Meek
Clinical Pharmacist
Principal Investigators
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Julie M Meek, PharmD
Role: PRINCIPAL_INVESTIGATOR
59th Medical Wing
Charles Reilly, MD
Role: STUDY_CHAIR
59th Medical Wing
Margaret Bonnie Rosbolt, PharmD, CCRC
Role: STUDY_DIRECTOR
59th Medical Wing
Locations
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Wilford Hall Medical Center - Refractive Surgery Center
Lackland Air Force Base, Texas, United States
Countries
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References
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Meek JM, Rosbolt MB, Taylor KR, Fusco EA, Panday VA, Reilly CD. Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study. J Ocul Pharmacol Ther. 2014 Sep;30(7):527-32. doi: 10.1089/jop.2013.0208. Epub 2014 Jun 10.
Other Identifiers
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FWH20100004H
Identifier Type: -
Identifier Source: org_study_id