Congenital Heart Disease in Children
Conditions
Keywords
pain control, cardiac surgery, pediatric, opioid, NSAID, congenital heart disease
Brief summary
The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.
Detailed description
The mainstay of postoperative pain control in the CVICU remains opiate-based therapy. Reliance on this class of medications can be detrimental, contributing to complications including hemodynamic instability, dependency, and withdrawal which can ultimately lead to longer hospital admissions, as well as long term and persistent neurodevelopmental effects. In addition, the opioid crisis has driven practitioners to aim for methods to reduce opioid exposure and post-operative narcotic prescriptions in pediatric and adult patients alike. There is a growing body of evidence in the adult literature showing promising results with the use of a continuous infusion of ketorolac in postoperative patients, including in a pediatric population. What the current literature has failed to show is whether a continuous infusion of ketorolac post operatively decreases the use of opiate mediations in a pediatric population compared to intermittent bolus injections, which is the current standard of care. Given the sensitivity and fragility inherent in those patients with CHD, working to reduce deleterious effects from excessive and prolonged opiate exposure is imperative. This study aims to examine whether the use of a continuous infusion of ketorolac can reduce the amount of opiates needed to treat postoperative pain control in the pediatric CVICU population, in comparison to patients who receive intermittent ketorolac within the first 72 hours post-operatively.
Interventions
DRUGContinuous ketorolac
Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte) for 48 hours.
Sponsors
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind
Intervention model description
Randomized, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
3 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
1. All patients aged 3 months to 4 years 11months admitted post operatively to the CVICU during the time period in which the study will be ongoing 2. Initiation of study medication within the first 12-24 hours post-operatively 3. The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control
Exclusion criteria
1. Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria. 2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications. 3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively 4. Orthotopic heart transplantation 5. Clinically significant bleeding 6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Total fentanyl dose equivalents received within the first 96 hours post-operatively | Within 72 hours of cardiac surgery | The total opioid receipt (converted to fentanyl equivalents) administered to patients enrolled in the study within the first 96 hours after cardiac surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Total fentanyl equivalents received in each 24 hour period before and after initiating the study drug | Within 72 hours after cardiac surgery | The total opioid receipt (converted to fentanyl equivalents) administered to patients enrolled in the study within each 24 hour period after cardiac surgery (up to 96 hours post-operatively). |
| Rate of acute kidney injury measured by pRIFLE criteria | Within 72 hours after cardiac surgery | Acute kidney injury rates |
| Major bleeding events | Within 72 hours after cardiac surgery | Hemoglobin decrease \> 2 g/dL, requirement of 2 or more units of PRBC's/whole blood, or development of symptomatic/clinically evident bleeding in any organ or compartment |
| Pain scores | Within 72 hours after cardiac surgery | FLACC scores (face, legs, activity, cry, consolability): score of 0-10 (10 being most severe pain, 0 being least severe). 0 = relaxed/comfortable, 1-3 = mild discomfort, 4-6 = moderate pain, 7-10 = severe discomfort or pain or both |
| Sedative agent requirements | Within 72 hours after cardiac surgery | Dose receipt/drug selection of sedative agents |
Countries
United States
Contacts
CONTACTKevin Engelhardt, MD
CONTACTSamantha Stack, BS
PRINCIPAL_INVESTIGATORKevin Engelhardt, MD
Heart Center
Outcome results
None listed