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

University Hospital Center (CHU)

Status and phase: Enrolling; Phase 2

Conditions: Pediatric Surgery; Anesthesia

Treatments: Other: Post-Hospitalization Behavior Questionnaire; Other: Face Legs Activity Cry Consolability scale; Other: Postoperative pain measure; Drug: Dexmedetomidine; Drug: Placebo administration; Other: Post-operative quality of life questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06736483

RECHMPL23_0433

2024-514550-73-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

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

Treatment:

Other: Post-operative quality of life questionnaire

Drug: Dexmedetomidine

Other: Postoperative pain measure

Other: Face Legs Activity Cry Consolability scale

Other: Post-Hospitalization Behavior Questionnaire

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Post-operative quality of life questionnaire

Drug: Placebo administration

Other: Postoperative pain measure

Other: Face Legs Activity Cry Consolability scale

Other: Post-Hospitalization Behavior Questionnaire