NCT00793910已完成不适用
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Level of Pain
研究概览
简要总结
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
- •Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
- •Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- •Access to transportation to meet follow-up requirements.
排除标准
- •Any reason to be excluded for PRK.
- •Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- •Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
- •Patients with known depressed renal function.
- •Any physical or mental impairment that would preclude participation in any of the examinations.
研究组 & 干预措施
Gabapentin
Active Comparator
oral medication
干预措施: Gabapentin (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Level of Pain
时间窗: 4 days postoperatively
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
次要结局
- Occurence of Use of Rescue Medication(2 hours to 4 days postoperatively)
研究者
Samantha B. Rodgers, MD
Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir
Fort Belvoir Community Hospital
研究点 (1)
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