Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

NCT06736483 | Recruiting Phase 2

• 2 other identifiers: RECHMPL23_04332024-514550-73-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

loco-regional anesthesia; Pain; Emergence delirium

Outcome Measures

Primary Outcomes (1)

• Rescue analgesic

  Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.

  From the end of surgery to hospital discharge (up to 7 days)

Secondary Outcomes (10)

• Postoperative pain

  From the end of surgery to hospital discharge (up to 2 days)

• Intraoperative morphine consumption

  From anesthesia induction to the end of surgery (up to 24 hours)

• Emergency analgesics

  From the end of surgery to hospital discharge (up to 24 hours)

• Adverse events

  From the end of surgery up to 7 postoperative days

• Length of hospital stay

  From the start of hospitalization to hospital discharge (up to 7 days)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.

Drug: Dexmedetomidine; Other: Face Legs Activity Cry Consolability scale; Other: Post-Hospitalization Behavior Questionnaire; Other: Postoperative pain measure; Other: Post-operative quality of life questionnaire

Placebo

PLACEBO COMPARATOR

Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision

Drug: Placebo administration; Other: Face Legs Activity Cry Consolability scale; Other: Post-Hospitalization Behavior Questionnaire; Other: Postoperative pain measure; Other: Post-operative quality of life questionnaire

Interventions

Dexmedetomidine DRUG

Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.

Dexmedetomidine

Placebo administration DRUG

Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision

Placebo

Face Legs Activity Cry Consolability scale OTHER

The pain will be assessed on admission and every 15 minutes until discharge from the PACU

Dexmedetomidine; Placebo

Post-Hospitalization Behavior Questionnaire OTHER

The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7

Dexmedetomidine; Placebo

Postoperative pain measure OTHER

The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months

Dexmedetomidine; Placebo

Post-operative quality of life questionnaire OTHER

The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months

Dexmedetomidine; Placebo

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1 to 7 years old male or female
• To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis
• Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
• National health insurance coverage
• Have obtained signed informed consent from holders of parental authority
• American Society of Anesthesiology (ASA) score : 1-2
• French read, written and spoken by legal representatives

You may not qualify if:

• Patient under 1 or over 8 years old
• Patients with allergies to local anesthetics
• Patient with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
• Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies)
• Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology.
• Patients and/or parents who refused to participate in the study
• Proven allergy or contraindication to dexmedetomidine or nalbuphine
• Previous study participants

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH of Montpellier

Montpellier, France, 34295, France

RECRUITING

MeSH Terms

Conditions

Pain; Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Julien PICO, MD

CONTACT

+33 7 88 01 44 14; j-pico@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 16, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): July 3, 2027
• Study Completion (Estimated): July 3, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

FR (1)