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Search / Trial NCT04040452

Continuous Vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Launched by PHOENIX CHILDREN'S HOSPITAL · Jul 29, 2019

Trial Information

Current as of July 28, 2025

Recruiting

Keywords

Pain Control Cardiac Surgery Pediatric Opioid Nsaid Congenital Heart Disease

ClinConnect Summary

This clinical trial is studying two different ways to give pain relief after heart surgery in young children with congenital heart disease. Researchers want to find out if giving a continuous infusion (steady drip) of a pain medication called ketorolac is more effective than giving it in smaller doses at intervals. The goal is to see if the continuous method can help reduce the need for stronger pain medications, like opioids, after surgery.

To be eligible for this trial, children aged between 3 months and 4 years who are recovering in the pediatric cardiovascular intensive care unit (CVICU) may participate, as long as they are expected to receive ketorolac for pain relief after their surgery. The study will start the medication within the first day after surgery. However, children with certain medical conditions, like severe kidney problems or significant bleeding issues, will not be included in the study. Participants can expect to be closely monitored throughout their recovery, and families will be provided with information and support during the trial.

Gender

ALL

Eligibility criteria

  • 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

About Phoenix Children's Hospital

Phoenix Children's Hospital is a leading pediatric healthcare institution dedicated to advancing child health through innovative research and clinical trials. With a commitment to providing exceptional care, the hospital leverages its extensive expertise in pediatric medicine to conduct rigorous clinical studies that aim to improve treatment outcomes and enhance the quality of life for children facing various health challenges. As a recognized center of excellence, Phoenix Children's Hospital collaborates with a network of healthcare professionals, researchers, and academic institutions to foster groundbreaking discoveries and ensure access to cutting-edge therapies for young patients.

Locations

Phoenix, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Kevin Engelhardt, MD

Principal Investigator

Heart Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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