METACEBO: Intraoperative Methadone in Children Undergoing Surgery

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04680286

Collaborator

(none)

Enrollment

Location

Arms

14.5

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Pain, Postoperative Children, Only	Drug: Methadone Hydrochloride Other: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial.Randomized controlled trial.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Other: Placebo Single dose, intravenous bolus. Administered as the experimental arm. Other Names: Saline
Experimental: 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.	Drug: Methadone Hydrochloride Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia. Other Names: Methadone

Arm

Intervention/Treatment

Placebo Comparator: 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.

Other: Placebo

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

Other Names:

Saline

Experimental: 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.

Drug: Methadone Hydrochloride

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

Other Names:

Methadone

Outcome Measures

Primary Outcome Measures

Patients consumption of analgesics in the PACU. [3 hours]
Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours).
Pain intensity (highest score) [3 hours]
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)

Secondary Outcome Measures

Readiness to discharge [6 hours]
Time for readiness to discharge from PACU assessed by PACU nurse.
Patients need of supplemental oxygen in PACU [3 hours]
Need of supplemental oxygen within the first 3 hours after extubation,(or until discharge from PACU, if discharged before 3 hours)
Awakenings during the first night after discharge. [24 hours]
Parents will answer whether the child have been awake and whether they believe the awakening(s) where due to pain.
Pain intensity the first postoperative day [48 hours]
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.
Analgesic consumption following discharge until evening on the first postoperative day [36 hours]
From discharge until 8 PM the first day following surgery. Collected by parents.
Unscheduled parental contacts to the hospital [4 days]
Parental contacts to hospital regarding pain and/or analgesics until 4 days following surgery.

Other Outcome Measures

FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, at home [48 hours]
Parental experience with assessment of the FLACC-score at home following discharge.