Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Anesthesia, Pediatric Surgery
In brief
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.
Key facts
- Study ID
- NCT06736483
- Run by
- University Hospital, Montpellier
- People needed
- 200
- Starts
- 2025-02-03
- Expected to finish
- 2028-07-03
- Last updated by the study team
- 2025-04-16
Who can join
Age: 1 and older, up to 7. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UH of Montpellier — Montpellier, France, France (enrolling)
Full record on ClinicalTrials.gov
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