deltatrials
Recruiting INTERVENTIONAL NCT04040452

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery (CIVIK)

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

Sponsor: Phoenix Children's Hospital

Updated 11 times since 2019 Last updated: Apr 22, 2026 Started: Mar 1, 2021 Primary completion: Jun 1, 2026 Completion: Dec 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Congenital Heart Disease in Children, this trial is actively recruiting participants. The trial is conducted by Phoenix Children's Hospital and has accumulated 11 data snapshots since 2021. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

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...

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.

Status Flow

~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshotNot Yet Recruiting~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshotNot Yet Recruiting~Jan 2022 – ~Feb 2023 · 13 months · monthly snapshotUnknown Status~Feb 2023 – ~Mar 2024 · 13 months · monthly snapshotRecruiting~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotRecruiting~Mar 2025 – ~Feb 2026 · 11 months · monthly snapshotRecruiting~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotRecruitingApr 28, 2026 – present · 2 months · daily APIRecruiting

Change History

11 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Recruiting

    Phase: PHASE4None

  2. Feb 2026 — Apr 2026 [monthly]

    Recruiting PHASE4

  3. Mar 2025 — Feb 2026 [monthly]

    Recruiting PHASE4

  4. Sep 2024 — Mar 2025 [monthly]

    Recruiting PHASE4

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE4

Show 6 earlier versions
  1. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE4

  2. Feb 2023 — Mar 2024 [monthly]

    Recruiting PHASE4

    Status: Unknown StatusRecruiting

  3. Jan 2022 — Feb 2023 [monthly]

    Unknown Status PHASE4

    Status: Not Yet RecruitingUnknown Status

  4. Jan 2021 — Jan 2022 [monthly]

    Not Yet Recruiting PHASE4

  5. Sep 2019 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE4

  6. Aug 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Phoenix Children's Hospital
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations