Clinical trial NCT04680286: Intraoperative Methadone in Children Undergoing Surgery
Official title: The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain, Acute
Pain, Postoperative
Children, Only
Keywords: methadone
analgesics
opioids
postoperative
placebo
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 60
Sex: MALE
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

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 open urological surgery.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients consumption of analgesics in the PACU.
timeFrame: 3 hours
measure: Pain intensity (highest score)
timeFrame: 3 hours
Secondary outcomes:
measure: Readiness to discharge
timeFrame: 6 hours
measure: Patients need of supplemental oxygen in PACU
timeFrame: 3 hours
measure: Awakenings during the first night after discharge.
timeFrame: 24 hours
measure: Pain intensity the first postoperative day
timeFrame: 48 hours
measure: Analgesic consumption following discharge until evening on the first postoperative day
timeFrame: 36 hours
measure: Unscheduled parental contacts to the hospital
timeFrame: 4 days
Other outcomes:
measure: FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, at home
timeFrame: 48 hours
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: