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Evaluation of Analgesia for Cardiac Elective Surgery in Children

ConditionPediatric Cardiac Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-18
SponsorSenthil Sadhasivam

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Methadone-Based ERAS GroupExperimental treatment 1 intervention
Group B: Non-Methadone-Based GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Postoperative 48 hours
2

Total postoperative opioid use

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

Time frame
Postoperative 48 hours

Secondary outcomes

1

Incidence of Inpatient Respiratory Depression (RD)

RD is defined as respiratory rate \<8 breaths per minute requiring oxygen in the absence of airway obstruction.

Time frame
Postoperative 120-hours
2

Incidence of Inpatient Postoperative Nausea and Vomiting (PONV)

PONV will be assessed by self-report, EMR, and medication use. Outcome measure will be reported as n(%).

Time frame
Postoperative 120-hours
3

Incidence of Inpatient Sedation

Sedation will be assessed using the Ramsay Sedation Scale (RSS) and validated sedation scales extracted from the EMR. Outcome measure will be reported as n(%)

Time frame
Postoperative 120-hours
4

QTc Prolongation

QTc prolongation is defined as more than 460 msec. Outcome measure will be reported as n(%).

Time frame
Postoperative 48-hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Senthil Sadhasivam

Lead sponsor

University of Pittsburgh

Sponsor institution

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

Collaborator

Source ClinicalTrials.gov
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