Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients

Who is this study for? Patients aged 3 months to 4 years undergoing cardiac surgery
What treatments are being studied? Ketorolac
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 4
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
Contact Information
Primary
Kevin Engelhardt, MD
kengelhardt@phoenixchildrens.com
6029333366
Backup
Samantha Stack, BS
sstack@phoenixchildrens.com
6029330607
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 166
Treatments
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)
Authors
Christopher A Thomas
Related Therapeutic Areas
Sponsors
Leads: Phoenix Children's Hospital

This content was sourced from clinicaltrials.gov