Clinical trial NCT06736483: Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Official title: Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: a Prospective, Randomized, Double-blind, Placebo-controlled Study. DEXPED
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anesthesia
Pediatric Surgery
Keywords: loco-regional anesthesia
Pain
Emergence delirium
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Postoperative pain, which can develop into chronic pain in children, can have a significant impact on the quality of life of the child and their parents. Management of acute postoperative pain is crucial to prevent chronic pain, and perioperative opioid sparing aims to reduce opioid side effects. The emergence of postoperative delirium (ED) is also a concern, as it can cause intense agitation and diagnostic difficulties. Dexmedetomidine, in addition to its sedative and analgesic effects, has been shown to prolong the duration and effectiveness of regional anesthesia (LAR), thereby reducing the need for opioids and attenuating the severity of postoperative delirium. Its use in these settings could improve pain management and reduce complications associated with pediatric surgery, thus offering a promising therapeutic option.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rescue analgesic
timeFrame: From the end of surgery to hospital discharge (up to 7 days)
Secondary outcomes:
measure: Postoperative pain
timeFrame: From the end of surgery to hospital discharge (up to 2 days)
measure: Intraoperative morphine consumption
timeFrame: From anesthesia induction to the end of surgery (up to 24 hours)
measure: Emergency analgesics
timeFrame: From the end of surgery to hospital discharge (up to 24 hours)
measure: Adverse events
timeFrame: From the end of surgery up to 7 postoperative days
measure: Length of hospital stay
timeFrame: From the start of hospitalization to hospital discharge (up to 7 days)
measure: Ped-PADSS score
timeFrame: From the end of surgery to hospital discharge (up to 2 days)
measure: Pediatric Anesthesia Emergence Delirium
timeFrame: From the end of surgery to hospital discharge (up to 24 hours)
measure: Post-Hospitalization Behavior Questionnaire
timeFrame: From the end of surgery up to 6 postoperative months
measure: Postoperative Pain Measure For Parents
timeFrame: From the end of surgery up to 6 postoperative months
measure: Post-operative quality of life questionnaire
timeFrame: From the end of surgery up to 6 postoperative months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH of Montpellier
Study officials:
References: