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Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

NCT06736483 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-16

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Pediatric Surgery

Interventions

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2027-07-03
Completion
2028-07-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736483 on ClinicalTrials.gov