Intraoperative Methadone in Children Undergoing Surgery (METACEBO)

University of Aarhus

Status and phase: Terminated; Phase 3

Conditions: Pain, Acute; Pain, Postoperative; Children, Only

Treatments: Other: Placebo; Drug: Methadone Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04680286

23956082

2020-002945-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: Under 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A 5 ml syringe with saline will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia.

Treatment:

Other: Placebo

Methadone

Experimental group

Description:

A 5 ml syringe with 1 mg/ml of methadone will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia.

Treatment:

Drug: Methadone Hydrochloride