Actively Recruiting
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Led by University Hospital, Montpellier · Updated on 2025-04-16
200
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 7 years old, male or female
- Scheduled for outpatient urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele repair)
- Receiving locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- Covered by national health insurance
- Signed informed consent from legal guardians
- American Society of Anesthesiology (ASA) score 1 or 2
- Legal representatives can read, write, and speak French
You will not qualify if you...
- Age under 1 or over 8 years old
- Allergies to local anesthetics
- Contraindication to locoregional anesthesia such as coagulation disorders or infection at the puncture site
- Contraindication to dexmedetomidine including hypersensitivity, advanced heart block (level 2 or 3), uncontrolled hypotension, or acute cerebrovascular disease
- Delayed psychological development, cognitive or behavioral disorders, or severe neurological disease
- Refusal to participate by patient or parents
- Proven allergy or contraindication to dexmedetomidine or nalbuphine
- Previous participation in this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
UH of Montpellier
Montpellier, France, France, 34295
Actively Recruiting
Research Team
J
Julien PICO, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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