Efficiency of IV Dexamethasone Compared to Placebo, Administrated After a Lower Limb Blockade is Done, on the Post Operative Pain in Children : a Controled, Randomised, Double Blind Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 主要终点
- Morphinic consumption in the post operative 24H
研究概览
简要总结
Intravenous dexamethasone (IV) can be used alone in adults as an adjunct to peri-nerves blocks, for diffusion blocks.
In pediatrics, dexamethasone is used daily according to the assessment of the anesthetist, by extension of the recommendations of the adult, as adjuvant in perinervous blocks although no study has been published yet concerning his interest. However, the physiology of the child is not superimposable to that of the adult (renal function, volume of distribution, plasma protein binding ...).
We thus wish to study the effectiveness of the administration of IV dexamethasone at the time of anesthetic induction in the prolongation of the duration of the block of the lower limbs in the child and its repercussion on the postoperative consumption of morphine.
Main Objective : Evaluate the efficiency, compared to placebo, of IV dexamethasone at the dose of 0.2 mg / kg administered as a bolus at the time of anesthetic induction, on the early postoperative pain (first 24 hours) in the child of 6 to 15 years undergoing surgery that requires the achievement of a peri-neural block of the lower limb after general anesthesia
Secondary objectives :
- Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the increase of the delay of first post operative morphinic consumption in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia.
- Evaluate that 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, doesn't increase the lower limb motor blokade duration in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia
- Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the decrease of post operative nausea and vomiting in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia
Principal endpoint :
-Morphinic consumption in the post operative 24H
Secondary endpoints :
- delay between the realisation of the lower limb blockade ans the first - consumption of morphinic
- duration the the motor blockade
- prevalence of post opérative nausea/vomiting
详细描述
Time 1: Pre-anesthetic consultation
Recruitment is performed during the pre-anesthetic consultation, between D-90 and D-2 of the date of operation. The eligibility criteria will be checked and if the child is eligible to participate in the study, oral and written information about the study is given to the child's parents (or, failing that, to their legal representatives) by the anesthetist doctor. Minors will receive information adapted to their ability to understand. It can not be overridden by the refusal of the child or the revocation of his acceptance. The investigator will give the parents the consent form The parents then have a minimum of 48 hours to decide whether to participate in the study of their child.
In all cases, an anesthesiologist doctor will be reachable (through the secretariat) at any time in case of additional questions during the reflection period.
Time n ° 2: Pre-anesthetic visit
If the parents and the child agree to participate in this study and after a new eligibility check, the consent signed by both parents will be collected the day before the intervention during the pre-anesthetic visit.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia with an anesthesic consultation between 90 to 2 days before the surgery
- •Legal guardian agreement
- •Children who are affiliated to the social security
- •Information of minor subjects adapted to their ability to understand
排除标准
- •Children who presents a contraindication to the single shot IV dexamethasone
- •Septic surgery
- •Corticoid treatment in the 7 days before the surgery - outpatient surgery
- •Handicapped or impaired children
- •Pregnant patient
- •Peri-nerval catheter
- •Children who are privated from their liberty because of a court or administrative decision or need psychiatric care
- •Uncontrolled psychotic state
- •Pregnant patients
研究组 & 干预措施
dexamethasone
IV dexamethasone group : dexamethasone administrated at the induction of general anesthesia, at the dose of 0,2mg/kg (= 0,2mL/kg of a syringe with a 1mg/mL concentration) maximum 8mg (=8mL).
干预措施: Dexamethasone (Drug)
Placebos
IV placebo group : saline serum is administrated at the induction of general anesthesia, at the dose of 0,2mL/kg, maximum 8mL.
干预措施: Placebos (Drug)
结局指标
主要结局
Morphinic consumption in the post operative 24H
时间窗: within 24 hours after dexamethasone or saline serum administration
total morphinic consumption in morphine equivalent in mg
次要结局
- Duration the the motor blockade(within 24 hours after dexamethasone or saline serum administration)
- Prevalence of post opérative nausea/vomiting(within 24 hours after dexamethasone or saline serum administration)
- Delay between the realisation of the lower limb blockade ans the first - consumption of morphinic(within 24 hours after dexamethasone or saline serum administration)