Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

NCT ID: NCT04040452

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2026-12-01

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.

Conditions

Congenital Heart Disease in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Continuous ketorolac

Intervention Type: DRUG

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.

Standard of care

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)

Group Type: PLACEBO_COMPARATOR

Continuous ketorolac

Intervention Type: DRUG

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.

Interventions

Continuous 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Engelhardt, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kevin Engelhardt, MD

Role: CONTACT

kengelhardt@phoenixchildrens.com

6029333366

Samantha Stack, BS

Role: CONTACT

sstack@phoenixchildrens.com

6029330607

Facility Contacts

Kevin Engelhardt, MD

Role: primary

kengelhardt@phoenixchildrens.com

6029333366

Samantha Stack, BS

Role: backup

sstack@phoenixchildrens.com

6029330607

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Other Identifiers

166166

Identifier Type: -

Identifier Source: org_study_id