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 groupsLocations
1UPMC Children's Hospital15213, PittsburghPennsylvania, United States
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