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Intravenous dexmedetomidine as an adjuvant to locoregional anesthesia in pediatric surgery: a prospective, randomized, double-blind, placebo-controlled study. DEXPED

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514550-73-00
Acronym
RECHMPL23_0433
Enrollment
200
Registered
2024-11-05
Start date
2025-02-03
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loco-regional anesthesia in pediatric surgery

Brief summary

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

Detailed description

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, Dose in milligrams of emergency analgesics in the PACU, 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), 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, 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

Interventions

DRUGDEXMEDETOMIDINE
DRUGSODIUM CHLORIDE

Sponsors

Centre Hospitalier Universitaire De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms

Secondary

MeasureTime frame
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, Dose in milligrams of emergency analgesics in the PACU, 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), 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, 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026