Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

Phase 2

Recruiting

• Conditions: Anesthesia; Pediatric Surgery
• Interventions: Drug: Dexmedetomidine; Drug: Placebo administration; Other: Face Legs Activity Cry Consolability scale; Other: Post-Hospitalization Behavior Questionnaire; Other: Postoperative pain measure; Other: Post-operative quality of life questionnaire

• Registration Number: NCT06736483
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-16
• Study Start: 2025-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-07-03
• Study Completion: 2028-07-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Post-Hospitalization Behavior Questionnaire	Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
Placebo	Postoperative pain measure	Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
Placebo	Post-operative quality of life questionnaire	Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
Dexmedetomidine	Dexmedetomidine	Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Dexmedetomidine	Face Legs Activity Cry Consolability scale	Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Dexmedetomidine	Post-Hospitalization Behavior Questionnaire	Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Dexmedetomidine	Postoperative pain measure	Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Dexmedetomidine	Post-operative quality of life questionnaire	Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Placebo	Placebo administration	Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
Placebo	Face Legs Activity Cry Consolability scale	Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision

Primary Outcome Measures

Name	Time	Method
Rescue analgesic	From the end of surgery to hospital discharge (up to 7 days)	Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	From the start of hospitalization to hospital discharge (up to 7 days)	Length of hospital stay in hours from admission to discharge
Ped-PADSS score	From the end of surgery to hospital discharge (up to 2 days)	The Post-Anesthetic Discharge Scoring System aimed to assess the possibility of discharge. The minimum is 0 and the maximum 10. A score of 9 or 10 authorizes hospital discharge.
Pediatric Anesthesia Emergence Delirium	From the end of surgery to hospital discharge (up to 24 hours)	Incidence of emergence of delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale. Score from 0 to 20, a score \> 9 indicates an emergence delirium
Post-Hospitalization Behavior Questionnaire	From the end of surgery up to 6 postoperative months	Post-Hospitalization Behavior Questionnaire at day 1 and day 7. This questionnaire is composed of 27 items rated from 1 to 5, minimum score : 27, maximum score: 135. A score above 68 is associated with an increase in postoperative behavioral problems.
Postoperative Pain Measure For Parents	From the end of surgery up to 6 postoperative months	Postoperative Pain Measure For Parents at 7 days, 3 and 6 months. Score: from 0 to 10 with 10 items. A score above 6 indicates significant pain.
Postoperative pain	From the end of surgery to hospital discharge (up to 2 days)	Assessment of postoperative pain using the Face Legs Activity Cry Consolability (FLACC) scale: on admission and every 15 minutes until discharge from the PACU, then before returning home.
Intraoperative morphine consumption	From anesthesia induction to the end of surgery (up to 24 hours)
Emergency analgesics	From the end of surgery to hospital discharge (up to 24 hours)	Dose in milligrams of emergency analgesics in the PACU
Adverse events	From the end of surgery up to 7 postoperative days	Incidence of opioid-related side effects (respiratory complications - postoperative nausea and vomiting)
Post-operative quality of life questionnaire	From the end of surgery up to 6 postoperative months	Post-operative quality of life questionnaire pedsQL at 3 and 6 months. The 23 questions cover 4 different domains: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items).; The parent questionnaire assesses parents' perceptions of their child's health-related quality of life.

Trial Locations

Locations (1)

UH of Montpellier; 🇫🇷 Montpellier, France