NCT06736483 Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
| NCT ID | NCT06736483 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Montpellier |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2027-07-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-02-03 with a primary completion date of 2027-07-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06736483 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 7 Years, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06736483 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06736483 currently recruiting?
Yes, NCT06736483 is actively recruiting participants. Contact the research team at j-pico@chu-montpellier.fr for enrollment information.
Where is the NCT06736483 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06736483 clinical trial?
NCT06736483 is sponsored by University Hospital, Montpellier. The trial plans to enroll 200 participants.