Effectiveness of melatonin prophylaxis on the post-operative pain and sensory recovery following mandibular fractures - A Randomized controlled clinical trail
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sensory recovery
研究概览
简要总结
Title of the study is Effectiveness of melatonin prophylaxis on post-operative pain and sensory recovery following mandibular fractures- a randomised controlled clinical trial. Aim of the study is to evaluate the effectiveness of melatonin prophylaxis on sensory recovery and post operative pain following surgery after mandibular fractures. The primary objective is to evaluate the efficacy of melatonin prophylaxis on sensory recovery. The secondary objective is to assess the efficacy of melatonin in reducing post surgical pain and numbness. the sample of the study is 24. 12 samples will be taken for each group, so a total of 24 samples will be taken and divided into two groups: study group and control group. The inclusion criteria is patients between 18 to 55 years coming to the hospital with mandibular fractures, and those who are fit for surgery under GA. The exclusion criteria is pregnancy and breastfeeding, renal and hepatic dosing, blood pressure, diabetic mellitus, autoimmune condition, patients consuming anti platelet drugs, anti coagulant drugs, anti convulsants,CNS depressants, seizure threshold lowering drugs, fluvoxamine, contraceptive drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patient fit for surgical procedure under general anesthesia 2 Patient reporting to the department OPD with mandibular fractures 3 Patient willing to participate in the study.
排除标准
- •1 Pregnancy and breast feeding 2 Hepatic dosing 3 Renal dosing 4 Auto Immune condition 5 Patient consuming anti platelet drugs 6 Patient consuming anti coagulant drugs 7 Patient consuming anti convulsant drugs 8 Patient consuming anti epileptic, CNS depressants drugs 9 Patients consuming oral contraceptives 10 Patient not willing to participate in the study.
结局指标
主要结局
Sensory recovery
时间窗: Post operative day 7,30 and 90
次要结局
- Post surgical pain & numbness(Post surgical pain - Post operative Day 1,3 & 7)
研究者
M Sai Shruthi
Sri Venkateshwaraa Dental College