Intraoperative Methadone in Children Undergoing Surgery

Phase 3

Terminated

• Conditions: Pain, Acute; Children, Only; Pain, Postoperative
• Interventions: Other: Placebo; Drug: Methadone Hydrochloride

• Registration Number: NCT04680286
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Status Verified: 2023-04
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A 5 ml syringe with saline will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia.
Methadone	Methadone Hydrochloride	A 5 ml syringe with 1 mg/ml of methadone will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Patients consumption of analgesics in the PACU.	3 hours	Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours).
Pain intensity (highest score)	3 hours	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)

Secondary Outcome Measures

Name	Time	Method
Readiness to discharge	6 hours	Time for readiness to discharge from PACU assessed by PACU nurse.
Unscheduled parental contacts to the hospital	4 days	Parental contacts to hospital regarding pain and/or analgesics until 4 days following surgery.
Analgesic consumption following discharge until evening on the first postoperative day	36 hours	From discharge until 8 PM the first day following surgery. Collected by parents.
Pain intensity the first postoperative day	48 hours	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.
Patients need of supplemental oxygen in PACU	3 hours	Need of supplemental oxygen within the first 3 hours after extubation,(or until discharge from PACU, if discharged before 3 hours)
Awakenings during the first night after discharge.	24 hours	Parents will answer whether the child have been awake and whether they believe the awakening(s) where due to pain.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark