Actively Recruiting

Phase 2
Age: 1Year - 7Years
All Genders
ID06736483

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

Led by University Hospital, Montpellier · Updated on 2025-04-16

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children aged 1 to 7 years undergoing specific outpatient surgeries such as orchidopexy or peritoneovaginal canal surgery. The study aims to assess if dexmedetomidine can reduce postoperative pain and related complications, including opioid use, emergence delirium, behavioral disorders, and hospital stay duration, to improve pain management and quality of life after surgery. Participants will be randomly assigned to receive either intravenous dexmedetomidine at a dose of 1 g/kg in sodium chloride or a placebo of sodium chloride alone, administered once at the time of surgical incision. The locoregional anesthesia techniques used include the Transversus Abdominis Plane (TAP) block and/or pudendal block. The study is double-blind and placebo-controlled. During the study, children and their legal representatives will complete various questionnaires at multiple time points: day 1, week 1, month 3, and month 6 after surgery. Pain will be regularly assessed in the post-anesthesia care unit using scales like the Face Legs Activity Cry Consolability scale. Researchers will monitor rescue analgesic use, opioid consumption, postoperative pain and delirium, adverse events, hospital stay length, behavioral changes, and quality of life. Participation lasts from surgery through six months of follow-up.

CONDITIONS

Brief Title

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Who Can Participate

Age: 1Year - 7Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 1 to 7 years old, male or female
  • Scheduled outpatient hospitalization for urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele repair)
  • Use of locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
  • National health insurance coverage
  • Signed informed consent obtained from holder(s) of parental authority
  • American Society of Anesthesiology (ASA) score of 1 or 2
  • Legal representatives able to read, write, and speak French
Not Eligible

You will not qualify if you...

  • Age under 1 year or over 8 years
  • Allergy to local anesthetics
  • Contraindication to locoregional anesthesia such as coagulation disorder or infection at puncture site
  • Contraindication to dexmedetomidine including hypersensitivity, advanced heart block (level 2 or 3), uncontrolled hypotension, or acute cerebrovascular events
  • 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

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 days or until hospital discharge

Participants receive intravenous dexmedetomidine or placebo at the time of surgery to support locoregional anesthesia and manage postoperative pain.

1 visit during surgery and daily assessments until discharge

Follow-up

Duration - 6 months

Participants are monitored for postoperative pain, behavior, and quality of life through questionnaires completed by parents up to 6 months after surgery.

Assessments at day 1, day 7, 3 months, and 6 months post-surgery

Trial Site Locations

Total: 1 location

1

UH of Montpellier

Montpellier, France, France, 34295

Actively Recruiting

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Research Team

J

Julien PICO, MD

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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