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Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Study acronym: DEXPED
StatusRecruiting
PhasePhase 2
Started2025-02-03
View on ClinicalTrials.gov ↗

Amendment history

2025-04-15
minor
Study Status, Oversight, Contacts/Locations v2
Primary completion date2027-07-02→2027-07-03
Completion date2028-07-02→2028-07-03
Start date2025-02-02→2025-02-03
Study sitesdetails revised at 1 of 1 site
2025-03-25
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-02→confirmed 2025-02-02
Study sites0→1
Study titlerevised
Intravenous Dexmedetomidine Asas an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
2024-12-13
minor
Original filing
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.
Trial Details
NCT Number NCT06736483
Lead Sponsor University Hospital, Montpellier
Conditions Anesthesia, Pediatric Surgery
Enrollment 200 participants
Start Date 2025-02-03
Primary Completion 2027-07-03 (estimated)
Study Completion 2028-07-03 (estimated)
Updated on ClinicalTrials.gov 2025-04-16