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临床试验/NCT01432977
NCT01432977已完成3 期

Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
-pain scores

研究概览

简要总结

The aim of this study is to demonstrate that the association paracetamol / ondansetron is not as effective as the association paracetamol / droperidol in the treatment of pain in children following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after

详细描述

Tonsillectomy is a common operation performed in children that is associated with marked pain and a high incidence of nausea and vomiting. Therefore, national and international guidelines have recommended the use of a setron as a prevention to nausea and vomiting and also the systematic administration of paracetamol to help in the control of postoperative pain. However, a potential interaction between setrons and paracetamol has been reported in different animal studies and in human volunteers although its existence has never been found in the clinic. Indeed, several hypotheses are proposed to explain the mechanism of action of paracetamol in the treatment of pain. However, a recent one involves the endocannabinoid system and spinal serotonin receptors. Serotonin receptors are also involved in the mechanism of action of antiemetics such as setrons. Indeed, these drugs are serotonin antagonists. Therefore, the investigators hypothesized that the concomitant administration of paracetamol and ondansetron leads to an interaction that will decrease the analgesic effect of paracetamol.

Patients aged 2-7 years old and scheduled for a tonsillectomy will be recruited. They will all receive intraoperatively intravenous paracetamol together with either ondansetron or droperidol. Pain scores using the CHEOPS scale will be recorded for 24 hours. Furthermore, patients will receive i.v. morphine during the operation and in the recovery room if necessary and a non-steroidal anti-inflammatory drug for postoperative pain; on the ward, oral codeine will be administered when needed. Pain scores will be recorded regularly for up to 24 hours together with opioid consumption and the incidence of nausea and vomiting in the same period. Any adverse event will also be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • tonsillectomy in a child 2-7 years old who is hospitalized for at least 24 hours ;
  • informed consent from one parent at least

排除标准

  • hospital stay of less than 24 hours ;
  • patient already on pain medication ;
  • allergic patient with a contra-indication to one of the study drugs.

研究组 & 干预措施

Eperimental

Experimental

paracetamol / ondansetron

干预措施: paracetamol / ondansetron (Drug)

comparateur

Active Comparator

paracetamol / droperidol

干预措施: paracetamol /droperidol (Drug)

结局指标

主要结局

-pain scores

时间窗: 4 hours after drug administration

pain scores at rest 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively

次要结局

  • analgesic consumption(24 hours after inclusion)
  • incidence of nausea and vomiting.(data continuiousley collected during 24 hours)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

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