Intraoperative Methadone in Children Undergoing Surgery

Study Overview
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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.

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.

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

Conditions
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Pain, Acute, Pain, Postoperative, Children, Only

Intervention / Treatment
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* Drug: Methadone Hydrochloride
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br>* Single dose, intravenous bolus. Administered as the experimental arm.<br>* Other names: Saline;|
| Experimental: Methadone<br>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. | Drug: Methadone Hydrochloride<br>* Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.<br>* Other names: Methadone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readiness to discharge | Time for readiness to discharge from PACU assessed by PACU nurse. | 6 hours | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Unscheduled parental contacts to the hospital | Parental contacts to hospital regarding pain and/or analgesics until 4 days following surgery. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methadone, analgesics, opioids, postoperative, placebo