Comparative evaluation of efficacy of single pre-emptive dose of Extended release Lornoxicam versus Prolonged release Diclofenac for surgical removal of impacted 3rd molar in Indian population: A prospective, randomized, triple blind, split mouth clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Pain evaluation using modified visual analogue scale (0-10)
研究概览
简要总结
Research Question
Is there any difference in the efficacy of Lornoxicam extended-release formulation and diclofenac prolonged-release formulation in managing postoperative pain and swelling in impacted mandibular 3rd molar surgeries?
AIM
To compare the efficacy of single pre-emptive dose of Extended release Lornoxicam and Prolonged release Diclofenac for surgical removal of impacted mandibular 3rd molar.
Primary Objective
• To compare the efficacy of Extended release Lornoxicam and Prolonged release Diclofenac in managing PAIN following impacted mandibular 3rd molar removal.
Secondary Objective
• To compare the efficacy of Extended release Lornoxicam and Prolonged release Diclofenac in managing SWELLING following impacted mandibular 3rd molar removal.
• To compare the time for 1st rescue analgesic in both the groups.
• To compare number of rescue analgesics needed in both the groups.
• To note the adverse events following administration of Lornoxicam ER and Diclofenac SR.
Null Hypothesis
There is no difference in the efficacy of extended release Lornoxicam and prolonged release Diclofenac in management of postoperative pain and swelling following impacted mandibular 3rd molar removal.
Alternative Hypothesis
There is a difference in the efficacy of extended release Lornoxicam and prolonged release Diclofenac in management of postoperative pain and swelling following impacted mandibular 3rd molar removal.
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 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
- •Patients who are willing to participate in the study 2.Patients requiring surgical extraction of bilateral impacted mandibular 3rd molar of similar difficulty (easy or moderate difficulty as per Pederson’s difficulty index) 3.Healthy patients belonging to ASA Class I or II will be included 4.Patients who are not on any pain management therapy or those who have not consumed any NSAID in the last seven days.
排除标准
- •1.Patients not willing to participate in the study 2.H/o Hypersensitivity reactions to Lornoxicam, Diclofenac or any other NSAID 3.Pregnant and lactating patients 4.Patients suffering from Bronchial Asthma or COPD or bleeding diathesis.
- •5.Patients with H/o gastritis, gastric/ duodenal ulcers, or any other inflammatory gastrointestinal disease 6.Pederson difficulty index score 7-10 (Difficult) 7.Patients having local signs of infection around the impacted tooth to be removed such as periapical abscess/granuloma, pericoronal abscess, fascial space infection etc.
结局指标
主要结局
Pain evaluation using modified visual analogue scale (0-10)
时间窗: 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
次要结局
- Swelling evaluation described by Gabka and Matsumara scale(Postoperative Day 1 and Postoperative Day 3)
研究者
Dr Charudatta Naik
Department of Oral and Maxillofacial Surgery