RECRUITING Phase 2 ClinicalTrials.gov

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Sponsor: University Hospital, Montpellier • ClinicalTrials.gov ID: NCT06736483

Registry updated: 2026-10-13

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Description

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.

Interventions

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

Conditions

Anesthesia Pediatric Surgery

Locations

UH of Montpellier — Montpellier, France, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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