Trial Outcomes & Findings for Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients (NCT NCT02558010)

NCT ID: NCT02558010

Last Updated: 2023-11-18

Results Overview

Total amount of opioids consumed during the first 72 hours after surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 58 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2023-11-18

Participant Flow

Participant milestones

Measure	Methadone Group Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg. Methadone: Perioperative IV methadone to be given Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.	Control Group Patient will receive normal saline placebo initially, then morphine prior to emergence. Normal Saline: control arm Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Overall Study STARTED	30	28
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

Baseline characteristics by cohort

Measure	Methadone Group n=25 Participants Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg. Methadone: Perioperative IV methadone to be given Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.	Control Group n=22 Participants Patient will receive normal saline placebo initially, then morphine prior to emergence. Normal Saline: control arm Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.	Total n=47 Participants Total of all reporting groups
Age, Continuous	15.0 years STANDARD_DEVIATION 1.8 • n=5 Participants	14.6 years STANDARD_DEVIATION 2.3 • n=7 Participants	14.81 years STANDARD_DEVIATION 2.06 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: All participants allocated to study groups, and received the intervention.

Total amount of opioids consumed during the first 72 hours after surgery.

Outcome measures

Measure	Methadone Group n=25 Participants Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg. Methadone: Perioperative IV methadone to be given Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.	Control Group n=22 Participants Patient will receive normal saline placebo initially, then morphine prior to emergence. Normal Saline: control arm Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Post-operative Opioid Consumption (mg/kg)	0.267 mg/kg Interval 0.119 to 0.451	0.340 mg/kg Interval 0.168 to 0.607

Adverse Events

Methadone Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Methadone Group n=25 participants at risk Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg. Methadone: Perioperative IV methadone to be given Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.	Control Group n=22 participants at risk Patient will receive normal saline placebo initially, then morphine prior to emergence. Normal Saline: control arm Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Respiratory, thoracic and mediastinal disorders Respiratory depression	4.0% 1/25 • Number of events 1 • Three post-operative days. Data represent the number of patients treated for each side effect, collapsed across post-operative days.	0.00% 0/22 • Three post-operative days. Data represent the number of patients treated for each side effect, collapsed across post-operative days.

Additional Information

Keri R. Hainsworth, PhD

Medical College of Wisconsin

Phone: 414-266-6306

Email: khainswo@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place