Recruiting
Phase 3

Methadone

Sponsor:

Senthil Sadhasivam

Code:

NCT06626035

Conditions

Pediatric Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Methadone based ERAS

Non-methadone based group

Study Details

Brief summary:

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.

Conditions

Pediatric Cardiac Surgery

Study ID

NCT06626035

Start date

Dec 17, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children aged 3-years - <18 years
  • ASA physical status 1, 2, or 3
  • Participant or legal guardian can speak and read English or Spanish
  • Undergoing the following cardiac surgeries (Categories 1 \& 2) that are associated with significant acute surgical pain

STS Category 1:

  • ASD, PFO closure
  • VSD repairs,
  • Aortic stenosis sub-valvular repair
  • ASD and Partial anomalous venous return repair
  • AV canal transitional
  • Conduit replacement
  • Valve replacement (AVR, PVR)
  • TOF repair without ventriculostomy

STS Category 2:

  • Glenn shunt (on Bypass only)
  • Fontan surgery (on Bypass only)
  • Pulmonary artery plasty (main)
  • Left Atrium (LA) to Pulmonary Artery (PA) conduit replacement.

Exclusion Criteria:

  • Pregnant patients
  • Methadone allergy
  • Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
  • Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
  • Preoperative opioid use within 30 days before surgery
  • History of severe sleep apnea (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness)
  • Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Methadone-Based ERAS Group

The methadone-based standardized analgesia intervention arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.

active comparator: Non-Methadone-Based Group

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.

Interventions

Methadone based ERAS

Children randomized to the methadone arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.

Non-methadone based group

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.

Primary outcome measure

  • Average postoperative pain scores [ Time Frame: Postoperative 48 hours ]
  • Total postoperative opioid use [ Time Frame: Postoperative 48 hours ]

Central Contacts and Locations

Central contacts

Senthilkumar Sadhasivam, MD,MPH, MBA, FASA

4126474484sadhasivams@upmc.edu

Dayana Alsamsam, BSPS, MSc

alsamsamd@upmc.edu

Locations

UPMC Children's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Senthilkumar Sadhasivam, MD, MPH

412-647-4484sadhasivams@upmc.edu

Alisha Maslanka, BS

412-491-2748maslankaaa@upmc.edu

Principal Investigator:

Senthilkumar Sadhasivam, MD

More Information

Sponsor

Senthil Sadhasivam

Last update posted

Aug 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Senthil Sadhasivam on 2026-08-07.