Intraoperative Methadone in Children Undergoing Surgery

Phase 3TerminatedNCT04680286

University of Aarhus60 enrolled

Overview

A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.

Treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. After discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals. In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Acute Pain, Postoperative Children, Only

Interventions

Methadone HydrochlorideDRUG

Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.

PlaceboOTHER

Single dose, intravenous bolus. Administered as the experimental arm.

Eligibility

Sex: MALEMin age: 0 YearsMax age: 4 Years

Medical Language ↔ Plain English

Inclusion Criteria: Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital. Exclusion Criteria: * Age =/\> 5 years at the date of operation * Born preterm (Before gestational age of 37 weeks) * Congenital heart disease * Previous scrotal surgery * Laparoscopic operation * American Society of Anaesthesiologists (ASA) physical status lll, IV or V * Allergy to study drugs * Preoperative daily use of opioids * Parents with inability to provide informed consent * Severe respiratory insufficiency * Acute abdominal pain * Severe kidney insufficiency * Treatment with rifampicin

Locations (1)

Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Patients consumption of analgesics in the PACU.

Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours).

Time frame: 3 hours

Pain intensity (highest score)

FLACC-score - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score. Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours)

Time frame: 3 hours

Secondary Outcomes

Readiness to discharge

Time for readiness to discharge from PACU assessed by PACU nurse.

Time frame: 6 hours

Patients need of supplemental oxygen in PACU

Need of supplemental oxygen within the first 3 hours after extubation,(or until discharge from PACU, if discharged before 3 hours)

Time frame: 3 hours

Awakenings during the first night after discharge.

Parents will answer whether the child have been awake and whether they believe the awakening(s) where due to pain.

Time frame: 24 hours

Pain intensity the first postoperative day

Assessed by parents, 3 FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, during the first postoperative day.

Time frame: 48 hours

Analgesic consumption following discharge until evening on the first postoperative day

From discharge until 8 PM the first day following surgery. Collected by parents.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.