Comparative evaluation of Palmitoylethanolamide (PEA) vs Ketorolac in Pain management after Third Molar Surgery A Randomised Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain intensity as measured by VAS scores at 24 and 48 hours post-surgery.
研究概览
简要总结
Comparative evaluation of Palmitoylethanolamide vs Ketorolac in pain management after 3rd molar surgery.
Non steroidal anti inflammatory drugs come with significant side effects. Palmitoylethanolamide an endogenous fatty acid has shown promise in managing pain with minimal side effects.
This study aims to compare the efficacy and safety of Palmitoylethanolamide against Ketorolac in this context.
This is a randomised, double blinded, control study.
Duration of study will be 6 months. 80 patients will be selected with a control group that will be given Ketorolac and a study group that will be given Palmitoylethanolamide.
Inclusion criteria will include patients aged between 18 to 40 with no systemic diseases or history smoking or consuming any other substances that will interfere with study. Exclusion criteria will be patients with known allergies to Ketorolac or Palmitoylethanolamide, history of gastric ulcers, renal or hepatic impairment, pregnant woman and lactating mother.
Pain will be assessed using VAS scale at multiple points post op.
The study aims to determine if Palmitoylethanolamide is as effective as Ketorolac with minimal side effects.
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 and Investigator Blinded
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 aged between 18 to 40 under going 3rd molar extraction.
- •No systemic disease.
- •Healthy human volunteer.
- •Does not smoke or consume any substance that interferes with study.
排除标准
- •Patients with known allergies to Palmitoylethanolamide or Ketorolac.
- •History of gastrointestinal ulcers, renal or hepatic impairment.
- •Pregnant woman and lactating mother.
结局指标
主要结局
Pain intensity as measured by VAS scores at 24 and 48 hours post-surgery.
时间窗: Pain intensity as measured by VAS scores at 24 and 48 hours post-surgery.
次要结局
- Total consumption of rescue medication.(Patient satisfaction scores.)
研究者
Dr. Nitin Bhagat
Manav Rachna Dental College