Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
NCT ID: NCT06736483
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-02-03
2028-07-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Dexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride 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
Placebo
Intravenous administration of 10 ml sodium chloride 0.9% 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Year
7 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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UH of Montpellier
Montpellier, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-514550-73-00
Identifier Type: CTIS
Identifier Source: secondary_id
RECHMPL23_0433
Identifier Type: -
Identifier Source: org_study_id
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