Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. DEXPED

2024-514550-73-00 Protocol RECHMPL23_0433 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 3 Feb 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol RECHMPL23_0433

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 200
Countries 1
Sites 2

Loco-regional anesthesia in pediatric surgery

To study the impact of intravenous (IV) dexmedetomidine combined with locoregional anesthesia (LRA) on postoperative pain in children undergoing surgery

Key facts

Sponsor
Centre Hospitalier Universitaire De Montpellier
Participant type
Pediatric, Patients
Age range
0-17 years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
Trial duration
3 Feb 2025 → ongoing
Decision date (initial)
2024-11-05
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
University Hospital of Montpellier and Nîmes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy, Efficacy

To study the impact of intravenous (IV) dexmedetomidine combined with locoregional anesthesia (LRA) on postoperative pain in children undergoing surgery

Secondary objectives 8

  1. Post-operative pain assessment in the Post-Anesthesia Care Unit (PACU)
  2. Assess intraoperative opioid consumption
  3. Assess PACU opioid consumption
  4. Assess the occurrence of opioid-related adverse events (nausea, vomiting)
  5. Evaluate length of stay in the PACU
  6. Assess the incidence of emergence delirium
  7. Assess the incidence of post-operative behavioral disorders
  8. Assess post-operative pain at home

Conditions and MedDRA coding

Loco-regional anesthesia in pediatric surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Age 1 to 7 years old male or female
  2. To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis or conventional hospitalization
  3. Locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
  4. National health insurance coverage
  5. Signed informed consent from holders of parental authority
  6. American Society of Anesthesiology (ASA) score: 1-2
  7. French read, written and spoken by legal representatives

Exclusion criteria 8

  1. Patients under 1 or over 8 years old
  2. Patients with allergies to local anesthetics
  3. Patients with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
  4. 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)
  5. Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology
  6. Patients and/or parents who refused to participate in the study
  7. Proven allergy or contraindication to dexmedetomidine or nalbuphine
  8. Previous study participants

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms

Secondary endpoints 9

  1. 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
  2. Intraoperative morphine consumption: Sufentanil, number of re-injections (0.1 µg/kg) required
  3. Dose in milligrams of emergency analgesics in the PACU
  4. Incidence of opioid-related side effects (respiratory complications, postoperative nausea and vomiting)
  5. Length of stay (from PACU entry to discharge based on Aldrete score > 9)
  6. Incidence of emergence delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale
  7. Post-Hospitalization Behavior Questionnaire at 7 days, 3, and 6 months
  8. Postoperative Pain Measure For Parents at 7 days, 3, and 6 months
  9. Post-operative quality of life questionnaire pedsQL at 7 days, 3 and 6 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dexmedetomidine

SUB07037MIG · Substance

Active substance
Dexmedetomidine
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1 µg/Kg microgram(s)/kilogram
Max total dose
1 µg/Kg microgram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Sodium Chloride

SUB12581MIG · Substance

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
90 mg milligram(s)
Max total dose
90 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Montpellier

19 Total trials 10 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier Universitaire De Montpellier
Address
191 Avenue Du Doyen Gaston Giraud
City
Montpellier Cedex 5
Postcode
34295
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire De Montpellier
Contact name
ISSA Amelle

Public contact point

Organisation
Centre Hospitalier Universitaire De Montpellier
Contact name
ISSA Amelle

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 200 2
Rest of world — 0 —

Investigational sites

France

2 sites · Ongoing, recruiting
Centre Hospitalier Universitaire De Montpellier
Anesthésie et Réanimation, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nimes
Anesthesia, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-02-03 2025-02-03

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocole_FP_DEXped 2.1
Recruitment arrangements (for publication) Recruitment_Procedure 1.1
Subject information and informed consent form (for publication) Consent_Form 1.2
Subject information and informed consent form (for publication) FLACC 1
Subject information and informed consent form (for publication) Guidelogicielparents_V1_DEXPED 1
Subject information and informed consent form (for publication) Information sheet 2
Subject information and informed consent form (for publication) Information sheet_5-7-ANS 2
Subject information and informed consent form (for publication) PAED 1
Subject information and informed consent form (for publication) Ped-PADSS 1
Subject information and informed consent form (for publication) PedsQL-Francais-enfant-5-7 ans 4.0
Subject information and informed consent form (for publication) PedsQL-Francais-parents-2-4 ans 4.0
Subject information and informed consent form (for publication) PHBQ 1
Subject information and informed consent form (for publication) PPMP 1
Summary of Product Characteristics (SmPC) (for publication) SmPC_DEXMEDETOMIDINE 1
Synopsis of the protocol (for publication) Synopsis_DEXPED 2.1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-29 France Acceptable
2024-10-18
 2024-11-05
2 SUBSTANTIAL MODIFICATION SM-1 2025-10-17 France Acceptable
2025-12-12
 2026-01-23