Using dexmedetomidine to improve pain management in children after surgery
Official title: Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
Run by University Hospital, Montpellier · NCT06736483 · Data updated 2026-11-12
This study is testing if giving children aged 1 to 7 dexmedetomidine during surgery can help reduce pain and the need for opioids afterward.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, France) |
| Status | Recruiting |
| Started | February 3, 2025 |
| Main results expected | July 3, 2028 |
| Study ends | July 3, 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06736483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1 to 7 years scheduled for specific outpatient surgeries requiring locoregional anesthesia.
✕Probably not a fit
Patients outside the age range of 1 to 8 years or those with contraindications to dexmedetomidine or locoregional anesthesia will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of intravenous dexmedetomidine as an adjuvant to locoregional anesthesia in pediatric patients undergoing surgery. The study aims to assess its impact on postoperative pain, opioid consumption, and the incidence of emergence delirium among other outcomes. Children aged 1 to 7 years will be randomized to receive either dexmedetomidine or a placebo at the time of incision. Participants will complete questionnaires at various time points post-surgery to evaluate pain management and overall satisfaction.
Why it matters
Potential benefit: If successful, this approach could significantly enhance postoperative pain management and reduce the need for opioids in children undergoing surgery.
How similar studies have gone: Previous studies have shown promising results with dexmedetomidine in similar settings, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UH of Montpellier
Montpellier, France, France Recruiting
Study contacts
- Study coordinator: Julien PICO, MD
- Email: j-pico@chu-montpellier.fr
- Phone: +33 7 88 01 44 14
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Video-based grading of intraoperative adverse events during pediatric laparoscopic appendectomy
This project tests whether using video recordings and ClassIntra can reliably grade intraoperative adverse events in children undergoing laparoscopic appendectomy.
-
Maltodextrin in the Preoperative Fast for Kids in ERAS
This pilot study tests whether giving maltodextrin before surgery helps reduce anxiety and improve recovery in children aged 3 to 8 undergoing elective day surgery.
-
VR preparation for kids before surgery
A small study tests whether a virtual reality tour of the hospital before surgery helps kids aged 3–12 feel less anxious and more cooperative.
-
Pediatric ERAS-Adapted Laparoscopic Appendectomy Feasibility
This study tests a 20-item enhanced recovery protocol in children aged 5–18 undergoing laparoscopic appendectomy to see if it can be safely and reliably applied in a real clinical setting.
-
A child-friendly way for kids to report their experiences around anesthesia and surgery
This project will test a Danish translation of a child-friendly recovery and experience questionnaire (PedSQoR) with 4–12-year-old surgical patients to let children report their own perioperative outcomes and experiences.
-
Caregiver health literacy in children's surgical care
This tests whether caregivers' health literacy and social circumstances are linked to caregiver anxiety before outpatient pediatric surgeries and to children's pain after surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.