Triple blind randomised control trial of two different treatment analgesic regimens following open reduction and internal fixation of mandibular fractures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The mandible is one of the most frequently fractured bones in the facial skeleton. Restoration of normal occlusion, bite function, and facial symmetry are the goals of mandibular fracture treatment. Successful treatment is also judged by the avoidance of functional limitations, including pain with mouth opening, impairment of jaw movements, or any healing complications. Postoperative pain control is an important outcome in assessing overall treatment success and patient satisfaction.High levels of acute postoperative pain have been reported to be associated with slower recovery of function and increased length of hospital stay. The availability of a wider selection of analgesics allows options that can provide better efficacy, and safer profile of adverse effects. A study of pain as an outcome after surgery ideally reports the specific type of analgesics given, uses validated pain assessments, and reports adverse effects related to the agent prescribed. Multiple oral health–related quality-of-life (QOL) instruments have been developed that are generic, organ specific, or condition specific and have been used in studies of patients who have had mandibular surgery.
Thus, this study is aimed to compare efficacy of two analgesics in pain control following open reduction and internal fixation of mandibular fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I, II AND III.
- •Mandibular fractures not associated with any acute infection.
排除标准
- •Patient with any systemic illness like cardiologic and neurologic disorders.
- •Patient with pathologic fractures, osteoradionecrosis, strictly non-operable cases and other facial fractures.
结局指标
主要结局
Pain
时间窗: Postoperative day 1 and day 2
次要结局
未报告次要终点
