Comparison of Inhalational Ketamine and Intravenous NSAID for analgesia in patients with acute renal colic in the Emergency Medicine - A Randomized Control Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To compare pain reduction after administration of nebulized Ketamine with that of intravenous Lornoxicam in patients with renal colic, measured using Numerical Rating Scale
研究概览
简要总结
This study is a randomized, double blind, parallel group,active controlled trial comparing inhalation ketamine and intravenous NSAID for analgesia in 200 patients with acute renal colic that will be conducted in a single centre in India. The primary outcome measures will be to compare pain reduction after administration of Nebulized Ketamine with that of IV Lornoxicam in patients suspected with renal colic, measured using NRS at 15, 30, 45 and 60 minutes. The secondary outcomes will be to observe time to significant pain relief, to assess need for rescue analgesia, to study incidence of adverse effects of both drugs and to assess the level of Patient satisfaction (on a score of 1-5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •1.Patients of age 18-65 years presenting with acute renal colic pain to the Emergency Department 2.Confirmed or highly suspected renal colic diagnosis (based on clinical presentation with or without imaging).
- •3.Pain score less than or equal to 5 on a 0 to 10 numerical rating scale 4.Warranted use of ketamine or NSAIDs as determined by treating physician 5.Patients had to be awake, alert, and oriented to person, place, and time.
排除标准
- •1.Imaging or Investigations indicating no renal or ureteric calculi 2.Known hypersensitivity to Ketamine or IV NSAIDS 3.Patients who received analgesics within 4 hours prior to ED arrival 4.Conditions where ketamine or NSAIDs are contraindicated – GI bleeding, AKI, CKD, Psychosis, CAD, CLD 5.Unstable vital signs (SBP less than 90 mm Hg or more than 180 mm Hg, Pulse less than 50 bpm or more than 150 bpm, or RR less than 10 or more than 30 bpm) 6.Conditions where peritoneal inflammation is suspected 7.Patients who are pregnant or breastfeeding 8.Patients with altered mental status and unable to give consent.
结局指标
主要结局
To compare pain reduction after administration of nebulized Ketamine with that of intravenous Lornoxicam in patients with renal colic, measured using Numerical Rating Scale
时间窗: 15, 30, 45 and 60 minutes
次要结局
- To observe time to significant pain relief (NRS fall more than or equal to 3)(Reassessed at 15, 30, 45 and 60 minutes)
- To assess the need for rescue analgesia using a strong opioid (IV Fentanyl)(Assessed at 15, 30, 45 and 60 minutes)
- To study acute adverse effect profile of both drugs
- To assess the level of Patient satisfaction (using 5 point Likert scale)
研究者
Dr. Aasif K Nazar
Malankara Orthodox Syrian Church Medical College Hospital