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Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

ConditionCongenital Heart Disease in Children
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-59
SponsorPhoenix Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Initiation of study medication within the first 12-24 hours post-operatively

The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control

Disqualifiers

Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria.

History of allergy or sensitivity reaction to ketorolac or any NSAID medications.

Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively

Orthotopic heart transplantation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous ketorolac

    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.

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: Standard of carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

1. Total fentanyl dose equivalents received within the first 96 hours post-operatively

The total opioid receipt (converted to fentanyl equivalents) administered to patients enrolled in the study within the first 96 hours after cardiac surgery.

Time frame
Within 72 hours of cardiac surgery

Secondary outcomes

1

1. Total fentanyl equivalents received in each 24 hour period before and after initiating the study drug

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).

Time frame
Within 72 hours after cardiac surgery
2

Rate of acute kidney injury measured by pRIFLE criteria

Acute kidney injury rates

Time frame
Within 72 hours after cardiac surgery
3

Major bleeding events

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

Time frame
Within 72 hours after cardiac surgery
4

Pain scores

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

Time frame
Within 72 hours after cardiac surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phoenix Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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