A Comparison of Pregabalin (Lyrica®) to Placebo in Postoperative Pain Relief of Patients Status-post Photorefractive Keratectomy: A Double-masked Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Clinical Efficacy
研究概览
简要总结
The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy ocular status
- •Stable preoperative refractive anisometropia
- •Consented to the PRK surgical procedure
排除标准
- •Pregnant or breastfeeding
- •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
研究组 & 干预措施
pregabalin
Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days
干预措施: pregabalin (Drug)
Placebo
Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Efficacy
时间窗: 5 days
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain.
次要结局
- Epithelial Healing Time(5 days or more)
- PPI Score(5 days)
- Quality of Life - BPI(5 days)
- Clinical Efficacy 2(5 days)
- Total MPQ Score(5 days)
研究者
Julie Meek
Clinical Pharmacist
59th Medical Wing