Intraoperative Methadone in Children Undergoing Surgery

NCT04680286 | Terminated Phase 3 DMC

• 2 other identifiers: 239560822020-002945-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Pain, Postoperative; Children, Only

Keywords

methadone; analgesics; opioids; postoperative; placebo

Outcome Measures

Primary Outcomes (2)

• Patients consumption of analgesics in the PACU.

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

  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)

  3 hours

Secondary Outcomes (6)

• Readiness to discharge

  6 hours

• Patients need of supplemental oxygen in PACU

  3 hours

• Awakenings during the first night after discharge.

  24 hours

• Pain intensity the first postoperative day

  48 hours

• Analgesic consumption following discharge until evening on the first postoperative day

  36 hours

Other Outcomes (1)

• FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, at home

  48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Methadone

EXPERIMENTAL

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.

Drug: Methadone Hydrochloride

Interventions

Methadone Hydrochloride DRUG

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

Also known as: Methadone

Methadone

Placebo OTHER

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 0 Years - 4 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Methadone; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 22, 2020
• Study Start: November 16, 2020
• Primary Completion: January 30, 2024
• Study Completion: February 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)