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

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

Treatments tested in this trial

Methadone based ERAS
Non-methadone based group

Treatment groups

500 Participants

are divided into 2 treatment groups

Sponsors and collaborators

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