Senthil Sadhasivam
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.
SPECIFIC AIMS. The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Cardiac) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing, and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after cardiac surgery (CS) in children. The long-term goal is to proactively improve the safety and efficacy of surgical pain control whil…
Inclusion Criteria: * 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) * Fontan surger…
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.
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.
Arctuva estimate
Verify or correct the compensation shown for this listing.