Continuous Vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Phase 4

Recruiting

• Conditions: Congenital Heart Disease in Children
• Interventions: Drug: Continuous ketorolac

• Registration Number: NCT04040452
• Lead Sponsor: Phoenix Children's Hospital

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.

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2021-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Continuous ketorolac	1. 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. 2. Dosage and Route of Administration: 1. 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. 2. Intermittent Plasmalyte 0.033mL/kg (max 2mL) infusion every 6 hours for 48 hours.
Standard of care	Continuous ketorolac	1. 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. 2. Dosage and Route of Administration 1. Continuous Plasmalyte infusion to match the aforementioned ketorolac dosing 2. Intermittent ketorolac 0.5mg/kg IV infusion every 6 hours (max 30mg per dose)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Sedative agent requirements	Within 72 hours after cardiac surgery	Dose receipt/drug selection of sedative agents
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

Trial Locations

Locations (1)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States