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Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

ConditionsAnesthesiaPediatric Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-7
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

  • Post-Hospitalization Behavior Questionnaire

    Other intervention

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

  • Postoperative pain measure

    Other intervention

    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 intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineExperimental treatment 5 interventions
Group B: PlaceboPlacebo comparator 5 interventions

Trial outcomes

Primary outcomes

1

Rescue analgesic

Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.

Time frame
From the end of surgery to hospital discharge (up to 7 days)

Secondary outcomes

1

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.

Time frame
From the end of surgery to hospital discharge (up to 2 days)
2

Intraoperative morphine consumption

Time frame
From anesthesia induction to the end of surgery (up to 24 hours)
3

Emergency analgesics

Dose in milligrams of emergency analgesics in the PACU

Time frame
From the end of surgery to hospital discharge (up to 24 hours)
4

Adverse events

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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