Clinical trial NCT04040452: Continuous Vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
Official title: Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Congenital Heart Disease in Children
Keywords: pain control
cardiac surgery
pediatric
opioid
NSAID
congenital heart disease
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 166
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1. Total fentanyl dose equivalents received within the first 96 hours post-operatively
timeFrame: Within 72 hours of cardiac surgery
Secondary outcomes:
measure: 1. Total fentanyl equivalents received in each 24 hour period before and after initiating the study drug
timeFrame: Within 72 hours after cardiac surgery
measure: Rate of acute kidney injury measured by pRIFLE criteria
timeFrame: Within 72 hours after cardiac surgery
measure: Major bleeding events
timeFrame: Within 72 hours after cardiac surgery
measure: Pain scores
timeFrame: Within 72 hours after cardiac surgery
measure: Sedative agent requirements
timeFrame: Within 72 hours after cardiac surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Heart Center
name: Kevin Engelhardt, MD
role: PRINCIPAL_INVESTIGATOR
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