The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial

23956082

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.

2020-11-16

2024-01-30

2024-02-01

Terminated

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2024-02-28