Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-7
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Dexmedetomidine
- Placebo administration
- Face Legs Activity Cry Consolability scale
- Post-Hospitalization Behavior Questionnaire
- Postoperative pain measure
- Post-operative quality of life questionnaire
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov