Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. DEXPED

Phase 2

Recruiting

• Conditions: Loco-regional anesthesia in pediatric surgery

• Registration Number: 2024-514550-73-00
• Lead Sponsor: Centre Hospitalier Universitaire De Montpellier

Brief Summary

To study the impact of intravenous (IV) dexmedetomidine combined with locoregional anesthesia (LRA) on postoperative pain in children undergoing surgery

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 200

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

Locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block

National health insurance coverage

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

Patients under 1 or over 8 years old

Patients with allergies to local anesthetics

Patients 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

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms		Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms

Secondary Outcome Measures

Name	Time	Method
Assessment of postoperative pain using the Face Legs Activity Cry Consolability (FLACC) scale: on admission and every 15 minutes until discharge from the PACU, then before returning home		Assessment of postoperative pain using the Face Legs Activity Cry Consolability (FLACC) scale: on admission and every 15 minutes until discharge from the PACU, then before returning home
Intraoperative morphine consumption: Sufentanil, number of re-injections (0.1 µg/kg) required		Intraoperative morphine consumption: Sufentanil, number of re-injections (0.1 µg/kg) required
Dose in milligrams of emergency analgesics in the PACU		Dose in milligrams of emergency analgesics in the PACU
Incidence of opioid-related side effects (respiratory complications, postoperative nausea and vomiting)		Incidence of opioid-related side effects (respiratory complications, postoperative nausea and vomiting)
Length of stay (from PACU entry to discharge based on Aldrete score > 9)		Length of stay (from PACU entry to discharge based on Aldrete score > 9)
Incidence of emergence delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale		Incidence of emergence delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale
Post-Hospitalization Behavior Questionnaire at 7 days, 3, and 6 months		Post-Hospitalization Behavior Questionnaire at 7 days, 3, and 6 months
Postoperative Pain Measure For Parents at 7 days, 3, and 6 months		Postoperative Pain Measure For Parents at 7 days, 3, and 6 months
Post-operative quality of life questionnaire pedsQL at 7 days, 3 and 6 months		Post-operative quality of life questionnaire pedsQL at 7 days, 3 and 6 months

Trial Locations

Locations (2)

Centre Hospitalier Universitaire De Montpellier; 🇫🇷 Montpellier Cedex 5, France

Centre Hospitalier Universitaire De Nimes; 🇫🇷 Nimes Cedex 9, France

Centre Hospitalier Universitaire De Montpellier

🇫🇷Montpellier Cedex 5, France

Julien PICO

Site contact

+33788014414

j-pico@chu-montpellier.fr