Status:
TERMINATED
Intraoperative Methadone in Children Undergoing Surgery
Lead Sponsor:
University of Aarhus
Conditions:
Pain, Acute
Pain, Postoperative
Eligibility:
MALE
Up to 4 years
Phase:
PHASE3
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 ope...
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 pe...
Eligibility Criteria
Inclusion
- Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04680286
Start Date
November 16 2020
End Date
February 1 2024
Last Update
February 28 2024
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200