Recruiting

Ketorolac vs. Ketorolac

Sponsor:

Phoenix Children's Hospital

Code:

NCT04040452

Conditions

Congenital Heart Disease in Children

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

Interventions

Continuous ketorolac

Study Details

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.

Conditions

Congenital Heart Disease in Children

Study ID

NCT04040452

Start date

Mar 1, 2021

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

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

Enrollment

166 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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)

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.

Primary outcome measure

  • 1. Total fentanyl dose equivalents received within the first 96 hours post-operatively [ Time Frame: Within 72 hours of cardiac surgery ]

Central Contacts and Locations

Central contacts

Kevin Engelhardt, MD

6029333366kengelhardt@phoenixchildrens.com

Samantha Stack, BS

6029330607sstack@phoenixchildrens.com

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Kevin Engelhardt, MD

6029333366kengelhardt@phoenixchildrens.com

Samantha Stack, BS

6029330607sstack@phoenixchildrens.com

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Keywords

  • pain control
  • cardiac surgery
  • pediatric
  • opioid
  • NSAID
  • congenital heart disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2026-08-12.