NCT06736483

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Postoperative pain, which can develop into chronic pain in children, can have a significant impact on the quality of life of the child and their parents. Management of acute postoperative pain is crucial to prevent chronic pain, and perioperative opioid sparing aims to reduce opioid side effects. The emergence of postoperative delirium (ED) is also a concern, as it can cause intense agitation and diagnostic difficulties. Dexmedetomidine, in addition to its sedative and analgesic effects, has been shown to prolong the duration and effectiveness of regional anesthesia (LAR), thereby reducing the need for opioids and attenuating the severity of postoperative delirium. Its use in these settings could improve pain management and reduce complications associated with pediatric surgery, thus offering a promising therapeutic option.

Conditions

• Anesthesia
• Pediatric Surgery

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
DRUG	Placebo administration	Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
OTHER	Face Legs Activity Cry Consolability scale	The pain will be assessed on admission and every 15 minutes until discharge from the PACU
OTHER	Post-Hospitalization Behavior Questionnaire	The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7
OTHER	Postoperative pain measure	The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months
OTHER	Post-operative quality of life questionnaire	The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months

Timeline

• Start date: 2025-02-03
• Primary completion: 2027-07-03
• Completion: 2028-07-03
• First posted: 2024-12-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: France