Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Официальное название

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Dexmedetomidine
  Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
• Препарат Placebo administration
  Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
• Другое Face Legs Activity Cry Consolability scale
  The pain will be assessed on admission and every 15 minutes until discharge from the PACU
• Другое Post-Hospitalization Behavior Questionnaire
  The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7
• Другое Postoperative pain measure
  The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months
• Другое Post-operative quality of life questionnaire
  The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months

Первичные конечные точки

• Rescue analgesic [Срок оценки: From the end of surgery to hospital discharge (up to 7 days)]

Вторичные конечные точки (10)

• Postoperative pain [Срок оценки: From the end of surgery to hospital discharge (up to 2 days)]
• Intraoperative morphine consumption [Срок оценки: From anesthesia induction to the end of surgery (up to 24 hours)]
• Emergency analgesics [Срок оценки: From the end of surgery to hospital discharge (up to 24 hours)]
• Adverse events [Срок оценки: From the end of surgery up to 7 postoperative days]
• Length of hospital stay [Срок оценки: From the start of hospitalization to hospital discharge (up to 7 days)]
• Ped-PADSS score [Срок оценки: From the end of surgery to hospital discharge (up to 2 days)]
• Pediatric Anesthesia Emergence Delirium [Срок оценки: From the end of surgery to hospital discharge (up to 24 hours)]
• Post-Hospitalization Behavior Questionnaire [Срок оценки: From the end of surgery up to 6 postoperative months]
• Postoperative Pain Measure For Parents [Срок оценки: From the end of surgery up to 6 postoperative months]
• Post-operative quality of life questionnaire [Срок оценки: From the end of surgery up to 6 postoperative months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• UH of Montpellier — Montpellier

Идентификаторы

NCT: NCT06736483 · RECHMPL23_0433 · 2024-514550-73-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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