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Trial record 46 of 465 for:    KETOROLAC

Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

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ClinicalTrials.gov Identifier: NCT04040452
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Phoenix Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease in Children Drug: Continuous ketorolac Phase 4

Detailed 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 96 hours post-operatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Supportive Care
Official Title: Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Treatment
  1. Description: Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte). To eliminate excess exposure and the associated side effects, all patients enrolled in the study will not be given any additional NSAIDs (except aspirin, which is standard of care in many post-operative cardiac surgery patients) during the study period.
  2. Dosage and Route of Administration:

    1. Continuous ketorolac 0.08mg/kg/hr, with a maximum of 5mg/hr for patients weighing greater than or equal to 60kg, administered intravenously by nursing staff. Study drug will infuse continuously for 48 hours.
    2. Intermittent Plasmalyte 0.033mL/kg (max 2mL) infusion every 6 hours for 48 hours.
Drug: Continuous ketorolac
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.

Placebo Comparator: Standard of care
  1. Description: Patients randomized to the standard of care arm of the study will receive a generically marked syringe of Plasmalyte to be infused at the same rate as the treatment medication, and will only receive intermittent dosing of ketorolac (current standard of care). As in the treatment group, no additional NSAIDs (except aspirin) are to be given during the 48 hour study period.
  2. Dosage and Route of Administration

    1. Continuous Plasmalyte infusion to match the aforementioned ketorolac dosing
    2. Intermittent ketorolac 0.5mg/kg IV infusion every 6 hours (max 30mg per dose)
Drug: Continuous ketorolac
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 Outcome Measures :
  1. 1. Total fentanyl dose equivalents received within the first 96 hours post-operatively [ Time Frame: Within 96 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 Outcome Measures :
  1. 1. Total fentanyl equivalents received in each 24 hour period before and after initiating the study drug [ Time Frame: Within 96 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 96 hours after cardiac surgery ]
    Acute kidney injury rates

  3. Major bleeding events [ Time Frame: Within 96 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 96 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 96 hours after cardiac surgery ]
    Dose receipt/drug selection of sedative agents



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Ages Eligible for Study:   3 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients aged 3 months to 4 years admitted post operatively to the CVICU during the 12 month time period during which the study will be ongoing
  2. Initiation of study medication within the first 48 hours post-operatively

Exclusion Criteria:

  1. Patients that have acute kidney injury, as defined by 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040452


Contacts
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Contact: Christopher A Thomas, PharmD 6029334028 cthomas1@phoenixchildrens.com
Contact: Allison Mruk, PharmD amruk@phoenixchildrens.com

Locations
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United States, Arizona
Phoenix Children's Hospital Not yet recruiting
Phoenix, Arizona, United States, 85016
Contact: Christopher A Thomas, PharmD    602-933-4028    cthomas1@phoenixchildrens.com   
Contact: Allison Mruk, PharmD       amruk@phoenixchildrens.com   
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
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Principal Investigator: Christopher A Thomas, PharmD Pharmacy Department

Publications:

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Responsible Party: Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT04040452     History of Changes
Other Study ID Numbers: 166166
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Phoenix Children's Hospital:
pain control
cardiac surgery
pediatric
opioid
NSAID
congenital heart disease

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action