Clonidine for Tourniquet-related Pain in Children: A Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total morphine T24
研究概览
简要总结
This study is designed as a randomized, placebo-controlled, double-blinded, clinical trial with two parallel groups.
This study investigates the association between a single dose of the drug, Clonidine, and the total amount of opioid administered under and 24 hours after surgery in children undergoing orthopedic limb surgery with the use of tourniquet.
The investigators hypothesize that administration of clonidine to children undergoing limb surgery with the use of inflatable tourniquets would reduce post-procedural pain.
This study is a pilot to obtain an effect size. Based on this the investigators will calculate a sample size for the main trial enabling us to reach a power of 0.8 with a significans level of 0.05.
详细描述
Pediatric upper and lower limb surgery often requires fine tissue handling. The prevention of blood flow to a limb allows surgical procedures to be performed with improved accuracy, safety, and speed. Surgical tourniquets, compressing devices used to control venous and arterial circulation to an extremity, enable the surgeons to work in a bloodless operative field.
Tourniquet related complications comprise severe pain during and after the procedure.
In infants and children, surgical procedures are performed under general anaesthesia (GA), comprising standard analgesics and anesthesia maintenance drugs. If an inflatable tourniquet is used, supplementary opioid analgesics are often required to relieve postoperative pain. This clinical observation is in accordance with previously reported data. In adult patients, surgical extremity procedures requiring tourniquets are well known to be painful. As a consequence, infants and children are subjected to prolonged stays in the recovery department. Mobilization and referral to a more child friendly environment might be delayed.
Many interventions and different medications have been tried in order to improve postoperative analgesia in pediatric patients. Amongst these Clonidine, primarily an alpha-2 adrenoceptor agonist. Clonidine stimulates alpha-2 adrenoceptors in the brain stem, thus activating inhibitory neurons, resulting in reduced sympathetic outflow from the CNS.
In several studies' clonidine administered orally or rectally before anesthesia has shown to reduce opioid use and diminish level of pain. Additionally, clonidine reduces the occurrence of postoperative agitation. As an adjuvant to central or peripheral nerve blocks, clonidine effectively prolongs analgesia. The efficacy of clonidine has also been investigated in clinical studies with pediatric ADHD patients Tourette's syndrome and stuttering. The efficacy of Clonidine in these conditions has not been demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I + II
- •Scheduled for GA and planned for relevant surgical procedure (according to table 1)
- •Planned use of surgical tourniquet on upper and/or lower extremity
排除标准
- •parental consent missing
- •ASA classification >II
- •Known diagnosis of QT-prolongation syndrome
- •known allergies to clonidine
- •known allergies or intolerance to morphine
- •daily use of pain killers
- •under treatment with antihypertensive and antiarrythmic medications
- •status of current or previous prematurity
- •planned for peripheral or central nerve block in addition to general anaesthesia
研究组 & 干预措施
Control group
IV Saline (Natriumklorid B.Braun 9mg/ml, B.Braun Melsungen AG, Melsungen, Tyskland) in an equal quantity as the study drug is administered at tourniquet inflation
干预措施: Saline (Other)
Intervention group
Catapressan (CatapresR Ampoules 150 micrograms in 1ml, Solution for injection, Boehringer Ingelheim Ltd., Berkshire, UK)(3mcg/kg) is administered at tourniquet inflation
干预措施: Catapresan (Drug)
结局指标
主要结局
Total morphine T24
时间窗: Through time spent in the Post-Anaesthesia Care Unit (PACU), i.e. from end-of-incision time to time of transferal from PACU to the paediatric ward, maxium up to 24 hours
Total amount of i.v. morphine in milligram (mg) administered per kg bodyweight from end-of-incision-time (T0) through the first 24 hours postoperatively (T24).
次要结局
- Morphine recovery to transferal to pediatric ward(Through time spent at the paediatric ward, i.e. from time of transferal from PACU to the paediatric ward to time of discharge up to 24 hours after end-of-incision-time)
- Morphine at pediatric ward to T24(Through time spent in the Post-Anaesthesia Care Unit (PACU), i.e. from end-of-incision time to time of transferal from PACU to the paediatric ward, maximum up to 24 hours)
- Total time at recovery(Through time spent in the Post-Anaesthesia Care Unit (PACU), i.e. from end-of-incision time to time of transferal from PACU to the paediatric ward, maximum up to 24 hours)
- Maximal pain(Through time spent in the Post-Anaesthesia Care Unit (PACU), i.e. from end-of-incision time to time of transferal from PACU to the paediatric ward, maximum up to 24 hours)
- Occurrence of emergence delirium(ED)(Through time spent in the Post-Anaesthesia Care Unit (PACU), i.e. from end-of-incision time to time of transferal from PACU to the paediatric ward, maximum up to 24 hours)
研究者
Nicola Groes Clausen
Principle Investigator
Odense University Hospital