Does Intraoperative Clonidine Reduce Post Operative Agitation in Children Anaesthetised With Sevoflurane? A RCT Including Pharmacokinetic Investigation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 3
- 主要终点
- Postoperative Agitation
研究概览
简要总结
Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.
In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.
详细描述
BACKGROUND:
Clonidine is widely used off-label in children for several indications such as treatment and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However, the current level of evidence in support of Clonidine treatment for postoperative agitation in children remains limited. In addition, the pharmacokinetic profile of intravenous Clonidine in children is not well characterized for age-groups.
METHODS/DESIGN:
In this prospective multicentre double-blinded randomized clinical trial, the investigators aim to investigate the impact of intravenous (IV) Clonidine administered at the end of surgery, on the incidence and degree of postoperative agitation. Children will be assigned to either the intervention or the placebo group. The allocation will be carried out centrally and stratified based on age and trial-site, with152 patients allocated to each group. In the intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20 minutes before the expected completion of the surgery (as assessed by the surgeon). In the control group; Saline (placebo) is injected in equal quantity during surgery at the same time. The drugs are concealed in identical blinded ampoules.
The primary outcome is postoperative agitation measured on the Watcha scale. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including 30-day follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for surgery with Sevoflurane as the choice of anesthesia.
排除标准
- •ASA classification >2
- •Premedication with Clonidine
- •Ex-premature (born before week 37+0 AND <60 weeks old)
- •Intubated before anaesthesia and/or no plans for extubation after anaesthesia.
- •Critical illness with haemodynamic instability.
- •Active bleeding.
- •Cardiac diseases including arrhythmias.
- •Malignant hyperthermia.
- •Mental retardation.
- •Neurological illness with agitation-like symptoms.
- •Weight >50 kg.
- •Allergy to Clonidine.
- •Patients treated with methylphenidate / Concerta.
研究组 & 干预措施
Intervention
Clonidine : injection og 3 micg/kg IV during the operation.
干预措施: Clonidine (Drug)
Placebo
Placebo : injection og equal amount of NaCl IV during the operation.
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Agitation
时间窗: 1 day
Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated
次要结局
- First Administration of Fentanyl or Morphine(recovery room)
- Fentanyl and Morphine Requirements(Recorded during the stay in the postoperative recovery room)
- Pain Assessment(recovery room - hours)
- Adverse Events(from intervention to discharge from the recovery room)
研究者
Mogens Ydemann
MD
Rigshospitalet, Denmark