Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Description

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.

Conditions

Congenital Heart Disease in Children

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Condition
Congenital Heart Disease in Children
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. All patients aged 3 months to 4 years 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
  • 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

Ages Eligible for Study

3 Months to 4 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Phoenix Children's Hospital,

Kevin Engelhardt, MD, PRINCIPAL_INVESTIGATOR, Heart Center

Study Record Dates

2025-12-01