Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.
研究概览
简要总结
The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.
详细描述
To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation
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
- 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
- 否
入选标准
- •patients over 18 years old
- •preoperative stable refraction for at least one-year,
- •normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.
排除标准
- •Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
- •amblyopic patients,
- •patients with a history of previous ocular surgeries,
- •herpetic eye infection, or corneal dystrophies.
- •Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
- •Diabetics,
- •Hypertensives,
- •Kidney problems,
- •breathing problems
- •Adults older than 65 years.
- •Previous allergy or adverse reaction to the used drugs.
- •History of drug abuse or alcohol abuse problems
- •History of mood problems, depression suicidal thoughts or behavior
研究组 & 干预措施
Gabapentin Group
The first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours
干预措施: Giving post photorefractive keratectomy for pain relief (Drug)
Diclofenac potassium Group
the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative.
All patients will be subjected to:
- History taking including sociodemographics, medical illnesses, and prior surgery or anesthetic experiences.
- Examination including assessment of vital data (heart rate, blood pressure, respiratory rate, level of consciousness, and respiratory examination.
干预措施: Giving post photorefractive keratectomy for pain relief (Drug)
结局指标
主要结局
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.
时间窗: 72 hours postoperative
pain assessment using Visual Analogue Scale
次要结局
未报告次要终点
研究者
Dina Moustafa Mohamed
Principal investigator
Research Institute of Ophthalmology, Egypt