Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

France · 1 center

• UH of Montpellier — Montpellier

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗