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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04680286
Other study ID # 23956082
Secondary ID 2020-002945-41
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 16, 2020
Est. completion date February 1, 2024

Study information

Verified date April 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals. In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date February 1, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 0 Years to 4 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methadone Hydrochloride
Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.
Other:
Placebo
Single dose, intravenous bolus. Administered as the experimental arm.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, at home Parental experience with assessment of the FLACC-score at home following discharge. 48 hours
Primary 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
Primary 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 Readiness to discharge Time for readiness to discharge from PACU assessed by PACU nurse. 6 hours
Secondary Patients need of supplemental oxygen in PACU Need of supplemental oxygen within the first 3 hours after extubation,(or until discharge from PACU, if discharged before 3 hours) 3 hours
Secondary Awakenings during the first night after discharge. Parents will answer whether the child have been awake and whether they believe the awakening(s) where due to pain. 24 hours
Secondary Pain intensity the first postoperative day Assessed by parents, 3 FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, during the first postoperative day. 48 hours
Secondary Analgesic consumption following discharge until evening on the first postoperative day From discharge until 8 PM the first day following surgery. Collected by parents. 36 hours
Secondary Unscheduled parental contacts to the hospital Parental contacts to hospital regarding pain and/or analgesics until 4 days following surgery. 4 days
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