Randomized, Controlled Cross-over Comparison of Cannabinoid to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pain as Recorded by the FACES Scale (Maximum) After First Surgery
研究概览
简要总结
Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
- •Consenting to participate
- •Not meeting exclusion criteria will be included in the study population.
排除标准
- •Patients not candidates for PRK will be excluded from the study.
- •Patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study.
- •Additional exclusion criteria will be known or suspected allergy or hypersensitivity to any of the routine or study medications.
- •Patients completing follow up appointments at anywhere other than UF Health Ophthalmology clinic at the Oaks will not be enrolled in the study.
- •Patients who are pregnant or nursing are not eligible for PRK, and such patients are not eligible to enroll in this study. Female patients of child-bearing age will be pregnancy tested before surgery and study enrollment.
- •Patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive THC urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.
研究组 & 干预措施
Oral cannabinoid
Oral cannabinoid
干预措施: oral cannabinoid (Drug)
Oral codeine/acetaminophen
Oral codeine-acetaminophen for controlling pain
干预措施: oral codeine/acetaminophen (Combination Product)
结局指标
主要结局
Pain as Recorded by the FACES Scale (Maximum) After First Surgery
时间窗: 1 week after first surgery
The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Pain as Recorded by the FACES Scale (Maximum) After Second Surgery
时间窗: 1 week after second surgery
The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
次要结局
- Uncorrected Visual Acuity of First Eye Surgery(3 months after first surgery)
- PROWL-SS(3 month)
- Quality of Life Refractive Correction Survey(3 months)
- Ocular Discomfort Questionnaire(3 months)
- Uncorrected Visual Acuity of Second Eye Surgery(3 months after second surgery)