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Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Recruiting
3 - 4 years of age
Both
Phase 4

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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.

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.

Eligibility

Inclusion 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

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

Study details

Congenital Heart Disease in Children

NCT04040452

Phoenix Children's Hospital

14 February 2024

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