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临床试验/CTRI/2024/01/061116
CTRI/2024/01/061116尚未招募Phase 3 4

A Comparative study of effect of administration of Ketamine and Paracetamol versus Paracetamol on postoperative pain, nausea and vomiting after pediatric Adenotonsillectomy

JLN Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Duration of analgesia and assesesment of pain.

研究概览

简要总结

This will be a hospital based prospective, randomized, double blind study conducted to compare the efficacy of administration of Ketamine and Paracetamol versus Paracetamol on postoperative pain, nausea, vomiting after pediatric adenotonsillectomy. For this study pediatric population is between 3 to 12 years of age group ASA grade 1 or 2 with exemption of all the exclusion criteria mentioned above and undergoing adenotonsillectomy under general anesthesia. The primary objective of the study is to assess the postoperative 12-hour pain score after administrating the drugs. The secondary objective of the study is to assess the duration of analgesia, episodes of nausea and vomiting, hemodynamic status before and after giving the analgesics and any complication associated. Participants will be allocated in two different group each with 40 number sample size. Group KP will receive Injection Ketamine (0.25mg/kg) with Paracetamol (15mg/kg) intravenously and group P will receive injection Paracetamol (15mg/kg). Both the drugs are administrated 15 minutes prior to the extubation. Preanesthetic evaluation will be done on the day before surgery. Since the patient enrolled in the surgery were children, patents need to give full information regarding the study with informed risk consent. All preparation for general anesthesia with emergency cart will be kept ready in prior. Child will be induced after proper preoxygenation and premedication and later with muscle relaxant in adequate dosage at optimum depth of anesthesia. Child will be administrated with above mentioned drugs 15 minutes prior to extubation. Patient will be monitored intraoperatively and postoperatively upto12 hours at pre described time interval and documented. Data will be analyzed statistically using standard quantitative and qualitative tests.

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
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective adenotonsillectomy ASA physical status 1 and 2.

排除标准

  • Age<2 years and > 12 years Emergency surgery Patient refusal Patient sensitive/ allergic to any of the drugs Patient with neuropsychiatric illness cardiovascular disease patient Coagulopathies Hepatic and Renal disease.

结局指标

主要结局

Duration of analgesia and assesesment of pain.

时间窗: Assessment of Children Hospital of Eastern Ontario Pain Scale (CHEOPS) in young children in postoperative period at immediatly after extubation,15 min, 30 min, 1hr,2hr,4hr,6hr and 12 hours.

次要结局

  • Duration of postoperative analgesia(Postoperative nausea & vomiting (PONV))

研究者

发起方
JLN Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Veena Mathur

JLN Medical College, Ajmer

研究点 (1)

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