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Compensation: Varies

Number of Visits: 1

Duration: 1 week

500 Participants Needed

Methadone-Based Recovery for Pediatric Cardiac Surgery
(PRECISE Trial)

Overseen ByAmy Monroe, MPH, MBA

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Senthil Sadhasivam

Must not be taking: Opioids

Disqualifiers: Adults, Pregnancy, ASA 3, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids before the surgery, you may not be eligible to participate.

What data supports the effectiveness of the drug methadone for recovery after pediatric cardiac surgery?

Research suggests that methadone can help reduce the need for other pain medications and lower pain scores in children after surgery, which may lead to shorter hospital stays and fewer side effects like constipation. It has been shown to be effective in providing long-lasting pain relief compared to other opioids.¹ ² ³ ⁴ ⁵

Is methadone safe for use in children undergoing surgery?

Methadone has been used in children for surgery-related pain and may reduce the need for other pain medications, but it can cause side effects like nausea, vomiting, and breathing problems. More research is needed to fully understand its safety in children.¹ ² ³ ⁶ ⁷

How is the drug methadone unique for pediatric cardiac surgery recovery?

Methadone is unique for pediatric cardiac surgery recovery because it has a longer duration of action and can reduce the need for other opioids and sedatives, potentially leading to shorter hospital stays and fewer side effects like constipation. It is used as a single-dose intravenous option to help with early extubation and better pain control compared to other opioids.¹ ² ³ ⁸ ⁹

What is the purpose of this trial?

The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50/50 chance, like a coin flip, of being assigned to either research group.

Research Team

Senthilkumar Sadhasivam, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for children undergoing elective cardiac surgery. Specific eligibility details are not provided, but typically participants must meet certain health criteria and have parental consent.

Inclusion Criteria

ASA physical status 1&2

I am having heart surgery that will cause a lot of pain right after.

Exclusion Criteria

Baseline prolonged QTc

Methadone/oxycodone allergy

I have been diagnosed with severe sleep apnea.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children undergo cardiac surgery and receive either methadone-based or standard-of-care analgesia protocols

1 week

Inpatient hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and adverse events post-surgery

3 months

Week 1 post-discharge, Month 1, and Month 3

Treatment Details

Interventions

Methadone

Trial Overview The study compares a methadone-based enhanced recovery after surgery (ERAS) protocol with the current standard of care in pediatric cardiac surgery. Children will be randomly assigned to either group.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Methadone-Based ERAS GroupExperimental Treatment1 Intervention

Children randomized to the methadone arm will receive standardized perioperative care and analgesia, including intraoperative intravenous methadone (0.1 mg/kg up to a maximum of 5 mg before incision and 0.05 mg at the end of surgery) and postoperatively, up to 4 oral doses of methadone every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.

Group II: SOC Non-Methadone-Based GroupActive Control1 Intervention

Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.

Methadone is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

Approved in United States as Dolophine for:

Pain management
Opioid use disorder

Approved in European Union as Methadose for:

Pain management
Opioid dependence

Approved in Canada as Physeptone for:

Pain management
Opioid use disorder

Approved in Japan as Heptadon for:

Pain management

Approved in Switzerland as Heptanon for:

Pain management
Opioid dependence

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Who Is Running the Clinical Trial?

Senthil Sadhasivam

Lead Sponsor

Trials

Recruited

4,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Methadone may be an effective option for postoperative pain control in children and adolescents, potentially reducing pain, opioid consumption, and the length of hospital stays, while also minimizing some side effects associated with traditional opioids.

Despite its benefits, methadone carries risks such as nausea, sedation, and QTc prolongation, highlighting the need for careful dosing protocols and further research to establish its safety and efficacy in various surgical contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What we know and what we don't know about the perioperative use of methadone in children and adolescents.Boisvert-Plante, V., Poulin-Harnois, C., Ingelmo, P., et al.[2023]

In a meta-analysis of 10 studies involving 617 surgical patients, those who received methadone had significantly lower postoperative opioid consumption compared to those who received other opioids, with a mean difference of -15.22 mg in oral morphine equivalents.

Patients receiving methadone also reported lower pain scores and higher satisfaction with their pain management, although the use of methadone carries risks such as respiratory depression and arrhythmia that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative methadone administration and postoperative pain control: a systematic review and meta-analysis.D'Souza, RS., Gurrieri, C., Johnson, RL., et al.[2021]