Evaluation of Analgesia for Cardiac Elective Surgery in Children

Conditions

• Pediatric Cardiac Surgery

Eligibility Criteria

Sex

ALL

Age

3 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Methadone based ERAS — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 17, 2025

Status verified

Apr 2026

Primary completion

Jan 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Average postoperative pain scores [ Time Frame: Postoperative 48 hours ]

Central Contacts

• Senthilkumar Sadhasivam, MD,MPH, MBA, FASA
  4126474484
  [email protected]
• Dayana Alsamsam, BSPS, MSc
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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