Methadone for children undergoing surgery

The use of intraoperative methadone in children undergoing open urological surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002945-41-DK

Enrollment

Registered

2020-08-09

Start date

2020-09-24

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in children undergoing open urological surgery MedDRA version: 20.0 Level: LLT Classification code 10031063 Term: Orchiopexy System Organ Class: 100000004865 MedDRA version: 20.0 Level: PT Classification code 10011498 Term: Cryptorchism System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: HLT Classification code 10022017 Term: Inguinal hernias System Organ Class: 100000004856 MedDRA version: 20.0 Level: PT Classification cod

Interventions

Trade Name: Methadone Streuli Sol Inj 10 mg/ml 10 AMPS 1 ML Product Name: Methadon Streuli Pharmaceutical Form: Solution for injection INN or Proposed INN: METHADONE CAS Number: 76-99-3 Concentration

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Children under the age of five, schedueled for open urologiscal surgery are screened for inclusion Are the trial subjects under 18? yes Number of subjects for this age range: 96 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Born preterm (Before gestational age of 37 weeks) • Congenital heart disease • Previous scrotal surgery • Laparoscopic operation • American Society of Anesthesiologists (ASA) physical status IV or V (21) • Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds) • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: • Consumption of analgesics within 3, 24 and 48 hours after extubation • Pain intensity (FLACC-score) every 15 minutes after extubation in the PACU, and 3 times the day following the first post operative surgery (morning, noon, afternoon) ;Secondary Objective: • Discharge time (minutes from extubation) • Sedation • Postoperative nausea and vomitting (PONV) within the first 48 hours ;Primary end point(s): • Consuption of analgesics • Painintensity;Timepoint(s) of evaluation of this end point: Within 3, 24 and 48 hours after extubation	—

Measure

Time frame

Main Objective: • Consumption of analgesics within 3, 24 and 48 hours after extubation • Pain intensity (FLACC-score) every 15 minutes after extubation in the PACU, and 3 times the day following the first post operative surgery (morning, noon, afternoon) ;Secondary Objective: • Discharge time (minutes from extubation) • Sedation • Postoperative nausea and vomitting (PONV) within the first 48 hours ;Primary end point(s): • Consuption of analgesics • Painintensity;Timepoint(s) of evaluation of this end point: Within 3, 24 and 48 hours after extubation

—

Secondary

Measure	Time frame
Secondary end point(s): • Discharge time (minutes from extubation) • Sedation within 3 hours • Postoperative nausea and vomitting (PONV) within the first 48 hours;Timepoint(s) of evaluation of this end point: • Within 3 hours • 48 hours	—

Countries

Denmark

Contacts

Public ContactLone Nikolajsen

Aarhus University Hospital

lone.nikolajsen@clin.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026