Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Congenital Heart Disease in Children
In brief
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 facts
- Study ID
- NCT04040452
- Run by
- Phoenix Children's Hospital
- People needed
- 166
- Starts
- 2021-03-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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