Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
Congenital Heart Disease in Children
About this trial
This is an interventional supportive care trial for Congenital Heart Disease in Children focused on measuring pain control, cardiac surgery, pediatric, opioid, NSAID, congenital heart disease
Eligibility Criteria
Inclusion Criteria:
- All patients aged 3 months to 4 years admitted post operatively to the CVICU during the 12 month time period during which the study will be ongoing
- Initiation of study medication within the first 48 hours post-operatively
Exclusion Criteria:
- Patients that have acute kidney injury, as defined by pRIFLE criteria.
- History of allergy or sensitivity reaction to ketorolac or any NSAID medications.
- Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively
- Orthotopic heart transplantation
- Clinically significant bleeding
Sites / Locations
- Phoenix Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment
Standard of care
Description: Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte). To eliminate excess exposure and the associated side effects, all patients enrolled in the study will not be given any additional NSAIDs (except aspirin, which is standard of care in many post-operative cardiac surgery patients) during the study period. Dosage and Route of Administration: Continuous ketorolac 0.08mg/kg/hr, with a maximum of 5mg/hr for patients weighing greater than or equal to 60kg, administered intravenously by nursing staff. Study drug will infuse continuously for 48 hours. Intermittent Plasmalyte 0.033mL/kg (max 2mL) infusion every 6 hours for 48 hours.
Description: Patients randomized to the standard of care arm of the study will receive a generically marked syringe of Plasmalyte to be infused at the same rate as the treatment medication, and will only receive intermittent dosing of ketorolac (current standard of care). As in the treatment group, no additional NSAIDs (except aspirin) are to be given during the 48 hour study period. Dosage and Route of Administration Continuous Plasmalyte infusion to match the aforementioned ketorolac dosing Intermittent ketorolac 0.5mg/kg IV infusion every 6 hours (max 30mg per dose)