RECRUITING

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04040452

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.

Ages Eligible for Study:3 Months to 4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Initiation of study medication within the first 12-24 hours post-operatively
  3. 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. 1. Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria.
  2. 2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications.
  3. 3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively
  4. 4. Orthotopic heart transplantation
  5. 5. Clinically significant bleeding
  6. 6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity

Contacts and Locations

Study Contact

Kevin Engelhardt, MD
CONTACT
6029333366
kengelhardt@phoenixchildrens.com
Samantha Stack, BS
CONTACT
6029330607
sstack@phoenixchildrens.com

Principal Investigator

Kevin Engelhardt, MD
PRINCIPAL_INVESTIGATOR
Heart Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Phoenix Children's Hospital

  • Kevin Engelhardt, MD, PRINCIPAL_INVESTIGATOR, Heart Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-03-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • pain control
  • cardiac surgery
  • pediatric
  • opioid
  • NSAID
  • congenital heart disease

Additional Relevant MeSH Terms

  • Congenital Heart Disease in Children