Using dexmedetomidine to improve pain management in children after surgery
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
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 |
| Enrollment | 200 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, France) |
| Trial ID | NCT06736483 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 7 years scheduled for specific outpatient surgeries requiring locoregional anesthesia.
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.
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 performed: Previous studies have shown promising results with dexmedetomidine in similar settings, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Montpellier, France
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.