Intraoperative Methadone in Children Undergoing Surgery

Pain, Postoperative Clinical Trial

— METACEBO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04680286
• Other study ID #: 23956082
• Secondary ID: 2020-002945-41
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Children, Only
• Pain, Acute
• Pain, Postoperative

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