跳至主要内容
临床试验/CTRI/2018/02/012260
CTRI/2018/02/012260已完成不适用

Triple blind randomised control trial of two different treatment analgesic regimens following open reduction and internal fixation of mandibular fractures.

SDM College of Dental Sciences and Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月11日最近更新:

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

研究者

发起方
SDM College of Dental Sciences and Hospital
申办方类型
Other [Private Dental College- SDM College of Dental Sciences and Hospital]

研究点 (1)

Loading locations...

相似试验