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Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures

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ClinicalTrials.gov Identifier: NCT04061330
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Paulina Sergot, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE August 15, 2019
First Posted Date  ICMJE August 19, 2019
Last Update Posted Date November 18, 2021
Estimated Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: baseline ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 5 minutes after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 10 minutes after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 30 minutes after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 60 minutes after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 2 hours after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 3 hours after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 4 hours after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 5 hours after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
  • Clinical pain as assessed by the Numerical pain rating score (NPRS) [ Time Frame: 6 hours after initial administration of drug ]
    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 5 minutes after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 10 minutes after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 30 minutes after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 60 minutes after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 2 hours after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 3 hours after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 4 hours after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 5 hours after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypoxic episodes as measured with a continuous pulse oximeter [ Time Frame: 6 hours after initial administration of drug ]
    Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
  • Number of hypotension episodes [ Time Frame: 5 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 10 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 30 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 60 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 2 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 3 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 4 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 5 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Number of hypotension episodes [ Time Frame: 6 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 5 minutes after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 10 minutes after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 30 minutes after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 60 minutes after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 2 hours after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 3 hours after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 4 hours after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 5 hours after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Score on Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 6 hours after initial administration of drug ]
    The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
  • Number of participants with need for rescue opioid therapy [ Time Frame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug) ]
  • Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria [ Time Frame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug) ]
  • Number of participants with Adverse reactions [ Time Frame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug) ]
  • Patient satisfaction with analgesia [ Time Frame: end of treatment (about 6 hours after initial administration of drug) ]
    Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
  • Physician satisfaction with analgesia [ Time Frame: end of treatment (about 6 hours after initial administration of drug) ]
    Physician satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
  • Nursing satisfaction with analgesia [ Time Frame: end of treatment (about 6 hours after initial administration of drug) ]
    Nursing satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Official Title  ICMJE Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Brief Summary The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain, Acute
Intervention  ICMJE
  • Drug: Ketamine
    Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.
  • Drug: Morphine
    Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.
Study Arms  ICMJE
  • Experimental: Ketamine Group
    Intervention: Drug: Ketamine
  • Active Comparator: Opioid group
    Intervention: Drug: Morphine
Publications * Not Provided

*   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: August 16, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.

Exclusion Criteria:

  • Received morphine in the ED prior to enrollment
  • Received ketamine any time prior to enrollment
  • Glasgow Coma Scale(GCS) less than 15
  • Transferred from other facility
  • Other moderate to severe trauma injuries
  • Contraindication to ketamine
  • Cannot consent (no intubation, airway issues, hemodynamic instability)
  • Prisoners
  • Suspected and/or confirmed pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paulina Sergot, MD (713) 500-7878 Paulina.B.Sergot@uth.tmc.edu
Contact: Misty Ottman 713-500-7870 Misty.Ottman@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04061330
Other Study ID Numbers  ICMJE HSC-MS-19-0580
Has Data Monitoring Committee No
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
Responsible Party Paulina Sergot, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paulina Sergot, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2021

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