Comparison of Pain relief with transdermal diclofenac patch and oral diclofenac sodium folloWing surgical removal of impacted mandibular third molars- a split mouth study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
In patients with bilaterally impacted mandibular third molar, following removal of the impacted third molar on one side, patients were given oral diclofenac 100mg daily in two divided doses for the 3 postoperative consecutive days. For the other side, a 100mg transdermal diclofenac patch was used. Drugs were administered one hour before surgery, with sides and drugs randomly chosen. Patients received both forms of intervention and could use oral paracetamol 500mg as rescue medication if needed in sustained pain. Pain was recorded using PRS and NRS scales at 2hr, 6hr and 12hr intervals for 72 hours postoperatively. The purpose of this trial is to compare the efficacy of transdermal diclofenac patch with oral diclofenac sodium in pain relief after surgical removal of impacted mandibular third molar and to compare the same with or without rescue medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting to Government dental College, Kottayam with bilateral impacted lower third molars.
排除标准
- •Patients on anticoagulant therapy.
- •Patients with uncontrolled systemic diseases.
- •Patients allergic to diclofenac or any NSAIDs.
结局指标
主要结局
Pain relief
时间窗: 2hours, 6hours and 12hours interval on 3 consecutive post operative days.
次要结局
- (Same as primary outcome).To compare pain relief following surgical removal of mandibular third molar with oral & transdermal diclofenac And also to compare the same with or without rescue medication using pain relief scale & numeric rating scale.((Same as for primary outcome)at an interval of 2hr, 6hr & 12hr for first 3 consecutive postoperative days.)
研究者
R Kavyaraj
Government Dental College, Kottayam