Intraoperative Methadone in Children Undergoing Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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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

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Pain, Acute Pain, Postoperative Children, Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose, intravenous bolus. Administered as the experimental arm.

Methadone

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.

Group Type EXPERIMENTAL

Methadone Hydrochloride

Intervention Type DRUG

Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.

Interventions

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Methadone Hydrochloride

Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.

Intervention Type DRUG

Placebo

Single dose, intravenous bolus. Administered as the experimental arm.

Intervention Type OTHER

Other Intervention Names

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Methadone Saline

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

4 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No