Methadone for children undergoing surgery

Phase 1

Conditions: Postoperative pain in children undergoing open urological surgery
MedDRA version: 20.0Level: LLTClassification code 10031063Term: OrchiopexySystem Organ Class: 100000004865
MedDRA version: 20.0Level: PTClassification code 10011498Term: CryptorchismSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0Level: HLTClassification code 10022017Term: Inguinal herniasSystem Organ Class: 100000004856
MedDRA version: 20.0Level: PTClassification code 10020488Term: HydroceleSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2020-002945-41-DK

Lead Sponsor: one Nikolajsen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 96

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Consumption of analgesics within 3, 24 and 48 hours after extubation<br>• 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)<br><br>;Secondary Objective: • Discharge time (minutes from extubation)<br>• Sedation<br>• Postoperative nausea and vomitting (PONV) within the first 48 hours<br>;Primary end point(s): • Consuption of analgesics<br>• Painintensity;Timepoint(s) of evaluation of this end point: Within 3, 24 and 48 hours after extubation

Secondary Outcome Measures

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