Comparative evaluation of the efficacy of fentanyl transdermal patch and oral diclofenac sodium for pain management following mandibular third molar surgery: a split-mouth randomised controlled study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VAS score for pain (1-10)
研究概览
简要总结
This study aims to compare the analgesic efficacy of fentanyl transdermal patch and oral diclofenac sodium in managing postoperative pain following bilateral mandibular third molar surgery using a split-mouth randomized controlled design. Twenty patients undergoing bilateral extractions will receive either a fentanyl patch or oral diclofenac sodium postoperatively in two separate sessions. Pain intensity will be assessed using the Visual Analogue Scale (VAS), along with measurements of postoperative swelling and maximum mouth opening. The study will evaluate differences in pain relief, patient recovery, and side-effect profiles between the two modalities to determine the feasibility of using fentanyl patches in acute dental pain management.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients requiring bilateral mandibular third molar surgery
- •Mandibular third molars with mild to moderate difficulty according to Pell and Gregory difficulty index
- •Patients with ASA I-II physical status.
排除标准
- •Patients requiring bilateral mandibular third molar surgery
- •Mandibular third molars with mild to moderate difficulty according to Pell and Gregory difficulty index
- •Patients with ASA I-II physical status.
结局指标
主要结局
VAS score for pain (1-10)
时间窗: Postoperatively at 1h, 12h, 24h and 72h
次要结局
- Post operative swelling will be assessed by a 5-line(measurement using a standard flexible tape.)
- Maximum mouth opening(preoperatively, then postoperatively at 24h and 72h)
研究者
Dr Chanchal Dharia
Terna Dental College and Hospital