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NCT Number: NCT06736483

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

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.

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Key information

Conditions

Anesthesia Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Surgery Postoperative Complications Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UH of Montpellier

Montpellier, France, 34295

Location status: Recruiting

Location contact

Julien PICO, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.

Placebo Administration

Drug

Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision

Face Legs Activity Cry Consolability scale

Other

The pain will be assessed on admission and every 15 minutes until discharge from the PACU

Post-Hospitalization Behavior Questionnaire

Other

The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7

Postoperative pain measure

Other

The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months

Post-operative quality of life questionnaire

Other

The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months

Primary outcomes

  1. Rescue analgesic

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: 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.

  2. Intraoperative morphine consumption

    Time frame: From anesthesia induction to the end of surgery (up to 24 hours)

  3. Emergency analgesics

    Time frame: From the end of surgery to hospital discharge (up to 24 hours)

    Dose in milligrams of emergency analgesics in the PACU

  4. Adverse events

    Time frame: From the end of surgery up to 7 postoperative days

    Incidence of opioid-related side effects (respiratory complications - postoperative nausea and vomiting)

  5. Length of hospital stay

    Time frame: From the start of hospitalization to hospital discharge (up to 7 days)

    Length of hospital stay in hours from admission to discharge

  6. Ped-PADSS score

    Time frame: 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.

  7. Pediatric Anesthesia Emergence Delirium

    Time frame: 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

  8. Post-Hospitalization Behavior Questionnaire

    Time frame: 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.

  9. Postoperative Pain Measure For Parents

    Time frame: 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.

  10. Post-operative quality of life questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julien PICO, MD

CONTACT

[email protected]

+33 7 88 01 44 14

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: DEXPED

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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