NCT04680286

Intraoperative Methadone in Children Undergoing Surgery

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Male
• Age: 0 Years – 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-16
• Primary completion: 2024-01-30
• Completion: 2024-02-01
• First posted: 2020-12-22
• Last updated: 2024-02-28

Locations

1 site across 1 country: Denmark