Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626035
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-15
Brief Title:
Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Analgesia for Cardiac Elective Surgery in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 5050 chance like a coin flip of being assigned to either research group
Detailed Description:
The investigators long-term goal is to proactively improve the safety and efficacy of surgical pain control while reducing opioid AEs adverse events and the opioid epidemic burden in all children undergoing inpatient surgeries The investigators central hypothesis is that a standardized multidose methadone-based ERAS Enhanced Recovery After Surgery protocol will reduce acute surgical pain overall opioid use RD Respiratory Depression PONV Postoperative Nausea and Vomiting and CPSP Chronic Persistent Surgical Pain compared with standard-of-care short-acting opioid-based analgesia in children undergoing CS Cardiac Surgery Aim 1 Investigators will use PK Pharmacokinetic and genetic variations along with CPB Cardiopulmonary Bypass related dilution and clinical factors to develop optimal intra- and post-operative methadone dosing in children to enable precision analgesia in the future Aim 2 The investigators will identify patient profiles with genetic epigenetic PK clinical and psychological factors to predict benefit from assigned analgesia for optimal clinical outcomes Aim 3 The investigators expert multidisciplinary and multicenter team will enroll a total of 500 children to conduct two parallel randomized clinical trials for CS 500 children 1 month-10 years from 5 clinical sites In this study specifically the investigators will
Aim 1 Conduct two randomized clinical trials in CS to compare acute pain relief opioid-sparing efficacy and safety of standardized perioperative multidose methadone-based ERAS vs standard-of-care non-methadone-based analgesia Acute surgical pain opioid needs morphine equivalents RD PONV and CPSP will be lower in methadone-based analgesia compared to short-acting opioid-based analgesia
Aim 2 Develop precision methadone dosing based on age CYP2B6 and ORM1 variants AAG and CPB Age CYP2B6 and ORM1 variants AAG levels and CPB-related dilution will explain methadones PK variability and dose adjustments that correlate with optimal clinical outcomes among 500 children receiving methadone
Aim 3 Identify patient profiles that predict benefits from the assigned analgesia protocol to optimize clinical outcomes Personalized risk prediction models will be developed and validated including genetic variants ie CYP2B6 CYP2D6 ABCB1 OPRM1 and FAAH and psychological and clinical factors to predict benefit with the assigned treatments methadone or non-methadone for pre-specified clinical endpoints
Overall Impact The investigators will develop actionable evidence for the efficacy of standardized multidose methadone-based ERAS protocols and will harness genetic clinical and psychological factors contributing to variability in methadone and oxycodone PK acute surgical pain transition to CPSP opioid-induced PONV RD and dependence to develop personalized analgesia strategy and dosing for children undergoing CS Implementation of evidence-based standardized methadone-based ERAS pain management and individualized risk prediction will maximize acute surgical pain relief while minimizing opioid use and AEs in millions of children
Aim 1 Conduct two randomized clinical trials in CS to compare acute pain relief opioid-sparing efficacy and safety of standardized perioperative multidose methadone-based ERAS vs standard-of-care non-methadone-based analgesia Acute surgical pain opioid needs morphine equivalents RD PONV and CPSP will be lower in methadone-based analgesia compared to short-acting opioid-based analgesia
Aim 2 Develop precision methadone dosing based on age CYP2B6 and ORM1 variants AAG and CPB Age CYP2B6 and ORM1 variants AAG levels and CPB-related dilution will explain methadones PK variability and dose adjustments that correlate with optimal clinical outcomes among 500 children receiving methadone
Aim 3 Identify patient profiles that predict benefits from the assigned analgesia protocol to optimize clinical outcomes Personalized risk prediction models will be developed and validated including genetic variants ie CYP2B6 CYP2D6 ABCB1 OPRM1 and FAAH and psychological and clinical factors to predict benefit with the assigned treatments methadone or non-methadone for pre-specified clinical endpoints
Overall Impact The investigators will develop actionable evidence for the efficacy of standardized multidose methadone-based ERAS protocols and will harness genetic clinical and psychological factors contributing to variability in methadone and oxycodone PK acute surgical pain transition to CPSP opioid-induced PONV RD and dependence to develop personalized analgesia strategy and dosing for children undergoing CS Implementation of evidence-based standardized methadone-based ERAS pain management and individualized risk prediction will maximize acute surgical pain relief while minimizing opioid use and AEs in millions of children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None