Status:
RECRUITING
Continuous Vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
Lead Sponsor:
Phoenix Children's Hospital
Conditions:
Congenital Heart Disease in Children
Eligibility:
All Genders
3-59 years
Phase:
PHASE4
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 ...
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 inst...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Clinically significant bleeding
- Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04040452
Start Date
March 1 2021
End Date
December 1 2026
Last Update
February 19 2025
Active Locations (1)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016