RecruitingPhase 4NCT04040452

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients


Sponsor

Phoenix Children's Hospital

Enrollment

166 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

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 pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.


Eligibility

Min Age: 3 MonthsMax Age: 59 Months

Inclusion Criteria3

  • 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 Criteria6

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGContinuous ketorolac

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.


Locations(1)

Phoenix Children's Hospital

Phoenix, Arizona, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04040452


Related Trials