Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rescue analgesic
研究概览
简要总结
The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery.
Secondary objectives was to compare beetwen groups : Post-operative pain; opioid consumption; incidence of emergence delirium, post-operative behavioral disorders, length of stay in the PACU, adverse events , parental satisfaction and quality of life.The goal of this clinical trial is to assess intravenous dexmedetomidine to prevent post-operative pain in children undergoing surgery.
This study is prospective and children will be randomized in one of the following arm:
- Dexmedetomidine (experimental treatment)
- Placebo The experimental treatment or placebo will be administrated at one time point at the time of incision.
Participants and their legal representative will have to respond to questionnaires at several time points following the surgery: Day 1, Week 1, Month 3 and Month 6.
详细描述
Postoperative pain, which can develop into chronic pain in children, can have a significant impact on the quality of life of the child and their parents. Management of acute postoperative pain is crucial to prevent chronic pain, and perioperative opioid sparing aims to reduce opioid side effects. The emergence of postoperative delirium (ED) is also a concern, as it can cause intense agitation and diagnostic difficulties. Dexmedetomidine, in addition to its sedative and analgesic effects, has been shown to prolong the duration and effectiveness of regional anesthesia (LAR), thereby reducing the need for opioids and attenuating the severity of postoperative delirium. Its use in these settings could improve pain management and reduce complications associated with pediatric surgery, thus offering a promising therapeutic option.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 to 7 years old male or female
- •To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis
- •Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- •National health insurance coverage
- •Have obtained signed informed consent from holders of parental authority
- •American Society of Anesthesiology (ASA) score : 1-2
- •French read, written and spoken by legal representatives
排除标准
- •Patient under 1 or over 8 years old
- •Patients with allergies to local anesthetics
- •Patient with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
- •Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies)
- •Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology.
- •Patients and/or parents who refused to participate in the study
- •Proven allergy or contraindication to dexmedetomidine or nalbuphine
- •Previous study participants
研究组 & 干预措施
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
干预措施: Face Legs Activity Cry Consolability scale (Other)
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
干预措施: Post-Hospitalization Behavior Questionnaire (Other)
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
干预措施: Postoperative pain measure (Other)
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
干预措施: Post-operative quality of life questionnaire (Other)
Placebo
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
干预措施: Placebo administration (Drug)
Placebo
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
干预措施: Face Legs Activity Cry Consolability scale (Other)
Placebo
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
干预措施: Post-Hospitalization Behavior Questionnaire (Other)
Placebo
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
干预措施: Postoperative pain measure (Other)
Placebo
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
干预措施: Post-operative quality of life questionnaire (Other)
结局指标
主要结局
Rescue analgesic
时间窗: From the end of surgery to hospital discharge (up to 7 days)
Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.
次要结局
- Length of hospital stay(From the start of hospitalization to hospital discharge (up to 7 days))
- Ped-PADSS score(From the end of surgery to hospital discharge (up to 2 days))
- Pediatric Anesthesia Emergence Delirium(From the end of surgery to hospital discharge (up to 24 hours))
- Post-Hospitalization Behavior Questionnaire(From the end of surgery up to 6 postoperative months)
- Postoperative Pain Measure For Parents(From the end of surgery up to 6 postoperative months)
- Postoperative pain(From the end of surgery to hospital discharge (up to 2 days))
- Intraoperative morphine consumption(From anesthesia induction to the end of surgery (up to 24 hours))
- Emergency analgesics(From the end of surgery to hospital discharge (up to 24 hours))
- Adverse events(From the end of surgery up to 7 postoperative days)
- Post-operative quality of life questionnaire(From the end of surgery up to 6 postoperative months)