Evaluation of Analgesia for Cardiac Elective Surgery in Children

NCT06626035 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY24040108U01HD116257
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Average postoperative pain scores

  Average postoperative pain scores within 48 hours of surgery (Numerical Rating Scale \[NRS\], or Facial expression, Leg movement, Activity, Cry, and Consolability \[FLACC\], both 0-10). Outcome will be reported based on area under the curve (AUC) as mean(SD).

  Postoperative 48 hours

• Total postoperative opioid use

  Total Opioid use in Morphine Milligram Equivalents (MME), will be reported as mean (SD).

  Postoperative 48 hours

Secondary Outcomes (8)

• Incidence of Inpatient Respiratory Depression (RD)

  Postoperative 120-hours

• Incidence of Inpatient Postoperative Nausea and Vomiting (PONV)

  Postoperative 120-hours

• Incidence of Inpatient Sedation

  Postoperative 120-hours

• QTc Prolongation

  Postoperative 48-hours

• Length of Hospital Stay (LOS)

  Up to 30 days

Study Arms (2)

Methadone-Based ERAS Group

EXPERIMENTAL

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.

Drug: Methadone based ERAS

Non-Methadone-Based Group

ACTIVE COMPARATOR

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.

Drug: Non-methadone based group

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.

Also known as: Methadone-Based

Methadone-Based ERAS Group

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.

Also known as: Standard Care

Non-Methadone-Based Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Senthil Sadhasivam: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Senthilkumar Sadhasivam, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senthilkumar Sadhasivam, MD,MPH, MBA, FASA

CONTACT

4126474484; sadhasivams@upmc.edu

Dayana Alsamsam, BSPS, MSc

CONTACT

alsamsamd@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: October 3, 2024
• Study Start: December 17, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Time frame is within 5-years of study completion.
• Access Criteria: Online collaborative tools to facilitate data sharing such as SharePoint or Xythos

Locations

US (1)