Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery (DEXPED)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Julien PICO, MD; Phone Number: +33 7 88 01 44 14; Email: j-pico@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH of Montpellier
    • Contact: Julien PICO, MD; Email: j-pico@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.	Drug: Dexmedetomidine; Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.; Other: Face Legs Activity Cry Consolability scale; The pain will be assessed on admission and every 15 minutes until discharge from the PACU; Other: Post-Hospitalization Behavior Questionnaire; The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7; Other: Postoperative pain measure; The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months; Other: Post-operative quality of life questionnaire; The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months
Placebo Comparator: Placebo; Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision	Other: Face Legs Activity Cry Consolability scale; The pain will be assessed on admission and every 15 minutes until discharge from the PACU; Other: Post-Hospitalization Behavior Questionnaire; The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7; Other: Postoperative pain measure; The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months; Other: Post-operative quality of life questionnaire; The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months; Drug: Placebo administration; Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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.	From the end of surgery to hospital discharge (up to 2 days)
Intraoperative morphine consumption		From anesthesia induction to the end of surgery (up to 24 hours)
Emergency analgesics	Dose in milligrams of emergency analgesics in the PACU	From the end of surgery to hospital discharge (up to 24 hours)
Adverse events	Incidence of opioid-related side effects (respiratory complications - postoperative nausea and vomiting)	From the end of surgery up to 7 postoperative days
Length of hospital stay	Length of hospital stay in hours from admission to discharge	From the start of hospitalization to hospital discharge (up to 7 days)
Ped-PADSS score	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.	From the end of surgery to hospital discharge (up to 2 days)
Pediatric Anesthesia Emergence Delirium	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	From the end of surgery to hospital discharge (up to 24 hours)
Post-Hospitalization Behavior Questionnaire	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.	From the end of surgery up to 6 postoperative months
Postoperative Pain Measure For Parents	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.	From the end of surgery up to 6 postoperative months
Post-operative quality of life questionnaire	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.	From the end of surgery up to 6 postoperative months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): July 3, 2027
• Study Completion (Estimated): July 3, 2028

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Emergence delirium; loco-regional anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: RECHMPL23_0433; 2024-514550-73-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No