Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Phoenix Children's Hospital
Study ID
NCT04040452
Phase
PHASE4
Status
Recruiting
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Conditions

  • Congenital Heart Disease in Children

Eligibility Criteria

Sex
ALL
Age
3 Months - 59 Months
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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)

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

Locations (1)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Kevin Engelhardt, MD
[email protected]
6029333366
Samantha Stack, BS
[email protected]
6029330607

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