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Trial record 46 of 469 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

Tracking Information
First Submitted Date  ICMJE July 29, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date August 2, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04040452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
  • 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).
  • Rate of acute kidney injury measured by pRIFLE criteria [ Time Frame: Within 96 hours after cardiac surgery ]
    Acute kidney injury rates
  • 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
  • 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
  • Sedative agent requirements [ Time Frame: Within 96 hours after cardiac surgery ]
    Dose receipt/drug selection of sedative agents
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • 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).
  • Rate of acute kidney injury measured by pRIFLE criteria [ Time Frame: Within 96 hours after cardiac surgery ]
    Acute kidney injury rates
  • 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
  • Pain scores [ Time Frame: Within 96 hours after cardiac surgery ]
    Pain scores
  • Sedative agent requirements [ Time Frame: Within 96 hours after cardiac surgery ]
    Dose receipt/drug selection of sedative agents
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
Official Title  ICMJE Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Congenital Heart Disease in Children
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Continuous ketorolac
  • 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)
    Intervention: Drug: Continuous ketorolac
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher A Thomas, PharmD 6029334028 cthomas1@phoenixchildrens.com
Contact: Allison Mruk, PharmD amruk@phoenixchildrens.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04040452
Other Study ID Numbers  ICMJE 166166
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not plan to make IPD available to other researchers.
Responsible Party Phoenix Children's Hospital
Study Sponsor  ICMJE Phoenix Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher A Thomas, PharmD Pharmacy Department
PRS Account Phoenix Children's Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP