Actively Recruiting
Study of Intravenous Dexmedetomidine to Reduce Pain After Pediatric Surgery with Locoregional Anesthesia in Children Ages 1 to 7
Led by University Hospital, Montpellier · Updated on 2025-04-16
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children aged 1 to 7 years undergoing specific outpatient surgeries such as orchidopexy or peritoneovaginal canal surgery. The study aims to assess if dexmedetomidine can reduce postoperative pain and related complications, including opioid use, emergence delirium, behavioral disorders, and hospital stay duration, to improve pain management and quality of life after surgery. Participants will be randomly assigned to receive either intravenous dexmedetomidine at a dose of 1 gkg in sodium chloride or a placebo of sodium chloride alone, administered once at the time of surgical incision. The locoregional anesthesia techniques used include the Transversus Abdominis Plane TAP block andor pudendal block. The study is double-blind and placebo-controlled. During the study, children and their legal representatives will complete various questionnaires at multiple time points day 1, week 1, month 3, and month 6 after surgery. Pain will be regularly assessed in the post-anesthesia care unit using scales like the Face Legs Activity Cry Consolability scale. Researchers will monitor rescue analgesic use, opioid consumption, postoperative pain and delirium, adverse events, hospital stay length, behavioral changes, and quality of life. Participation lasts from surgery through six months of follow-up.
CONDITIONS
Brief Title
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Research Team
J
Julien PICO, MD
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