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NCT Number: NCT04040452

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

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.

Recruiting

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Key information

Age range

3 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Continuous ketorolac

Drug

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.

Primary outcomes

  1. 1. Total fentanyl dose equivalents received within the first 96 hours post-operatively

    Time frame: Within 72 hours of cardiac surgery

    The total opioid receipt (converted to fentanyl equivalents) administered to patients enrolled in the study within the first 96 hours after cardiac surgery.

Secondary outcomes

  1. 1. Total fentanyl equivalents received in each 24 hour period before and after initiating the study drug

    Time frame: Within 72 hours after cardiac surgery

    The total opioid receipt (converted to fentanyl equivalents) administered to patients enrolled in the study within each 24 hour period after cardiac surgery (up to 96 hours post-operatively).

  2. Rate of acute kidney injury measured by pRIFLE criteria

    Time frame: Within 72 hours after cardiac surgery

    Acute kidney injury rates

  3. Major bleeding events

    Time frame: Within 72 hours after cardiac surgery

    Hemoglobin decrease > 2 g/dL, requirement of 2 or more units of PRBC's/whole blood, or development of symptomatic/clinically evident bleeding in any organ or compartment

  4. Pain scores

    Time frame: Within 72 hours after cardiac surgery

    FLACC scores (face, legs, activity, cry, consolability): score of 0-10 (10 being most severe pain, 0 being least severe). 0 = relaxed/comfortable, 1-3 = mild discomfort, 4-6 = moderate pain, 7-10 = severe discomfort or pain or both

  5. Sedative agent requirements

    Time frame: Within 72 hours after cardiac surgery

    Dose receipt/drug selection of sedative agents

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Engelhardt, MD

CONTACT

[email protected]

6029333366

Samantha Stack, BS

CONTACT

[email protected]

6029330607

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Acronym: CIVIK

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2019
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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