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Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Sponsor: University Hospital, Montpellier
Summary
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.
Official title: Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
Key Details
Gender
All
Age Range
1 Year - 7 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-02-03
Completion Date
2028-07-03
Last Updated
2025-04-16
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Placebo administration
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
Face Legs Activity Cry Consolability scale
The pain will be assessed on admission and every 15 minutes until discharge from the PACU
Post-Hospitalization Behavior Questionnaire
The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7
Postoperative pain measure
The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months
Post-operative quality of life questionnaire
The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months
Locations (1)
UH of Montpellier
Montpellier, France, France