What this study is
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.
What's being tested
- Continuous ketorolac
Intervention · 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
- Official title
- Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients
- Sponsor
- Phoenix Children's Hospital
- Conditions
- Congenital Heart Disease in Children
- Enrolling
- 166 people
- Starts
- 2021-03-01
- Est. completion
- 2027-12-01
- Design
- Triple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Months – 59 MonthsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPhoenix Children's Hospital
Phoenix, Arizona, United States
- Kevin Engelhardt, MD · Contact6029333366kengelhardt@phoenixchildrens.com
- Samantha Stack, BS · Contact6029330607sstack@phoenixchildrens.com
Recruiting
Study team
Sponsor
Phoenix Children's Hospital
Study ID 19-554
Principal investigator
Kevin Engelhardt, MD
Heart Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.