Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The mainstay of postoperative pain control in the CVICU remains opiate-based therapy. Reliance on this class of medications can be detrimental, contributing to complications including hemodynamic instability, dependency, and withdrawal which can ultimately lead to longer hospital admissions, as well as long term and persistent neurodevelopmental effects. In addition, the opioid crisis has driven practitioners to aim for methods to reduce opioid exposure and post-operative narcotic prescriptions in pediatric and adult patients alike. There is a growing body of evidence in the adult literature showing promising results with the use of a continuous infusion of ketorolac in postoperative patients, including in a pediatric population. What the current literature has failed to show is whether a continuous infusion of ketorolac post operatively decreases the use of opiate mediations in a pediatric population compared to intermittent bolus injections, which is the current standard of care. Given the sensitivity and fragility inherent in those patients with CHD, working to reduce deleterious effects from excessive and prolonged opiate exposure is imperative. This study aims to examine whether the use of a continuous infusion of ketorolac can reduce the amount of opiates needed to treat postoperative pain control in the pediatric CVICU population, in comparison to patients who receive intermittent ketorolac within the first 72 hours post-operatively. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04040452
Study type Interventional
Source Phoenix Children's Hospital
Contact Kevin Engelhardt, MD
Phone 6029333366
Email kengelhardt@phoenixchildrens.com
Status Recruiting
Phase Phase 4
Start date March 1, 2021
Completion date December 1, 2025

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05975658 - WIReD: Wireless Interstage Remote Device Study
Completed NCT05546983 - How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
Completed NCT03229538 - STeroids to REduce Systemic Inflammation After Infant Heart Surgery Phase 3
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Recruiting NCT05128084 - Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
Recruiting NCT04604418 - Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Completed NCT05778240 - Adherence to Palivizumab Prophylaxis N/A
Completed NCT04666857 - Family Centred Early Intervention of Infants With Congenital Heart Disease N/A
Terminated NCT03136900 - Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants. N/A
Recruiting NCT05910320 - Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants N/A
Not yet recruiting NCT05778175 - Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
Completed NCT05284500 - Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery
Completed NCT04295239 - Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery N/A
Completed NCT05142046 - Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Recruiting NCT05268094 - Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) N/A
Recruiting NCT04315610 - Personalized Mobile App for Parents of Infants With Cardiac Disease N/A
Completed NCT04018079 - Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Recruiting NCT05496803 - Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization. N/A
Recruiting NCT05826769 - To Assess the Efficacy of Early Administration of Energy Enriched and Protein Enriched Formula in Post Cardiac Repair Infants: a Randomized Controlled Trial, Comparative Study N/A
Recruiting NCT04307030 - Study on AI Recognition System Of Heart Sound In Congenital Heart Disease Screening