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Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

RecruitingPhase 4Ages 3 Months - 59 MonthsAllPhoenix Children's Hospital
NCT04040452 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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 2. Initiation of study medication within the first 12-24 hours post-operatively 3. 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 Criteria: 1. Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria. 2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications. 3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively 4. Orthotopic heart transplantation 5. Clinically significant bleeding 6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity
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What it tests

  • Continuous ketorolac
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Where

1 site
Phoenix Children's Hospital
Phoenix, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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