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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 : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Paulina Sergot, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: Ketamine Drug: Morphine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine Group 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.

Active Comparator: Opioid group 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Number of hypotension episodes [ Time Frame: 5 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  11. Number of hypotension episodes [ Time Frame: 10 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  12. Number of hypotension episodes [ Time Frame: 30 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  13. Number of hypotension episodes [ Time Frame: 60 minutes after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  14. Number of hypotension episodes [ Time Frame: 2 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  15. Number of hypotension episodes [ Time Frame: 3 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  16. Number of hypotension episodes [ Time Frame: 4 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  17. Number of hypotension episodes [ Time Frame: 5 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  18. Number of hypotension episodes [ Time Frame: 6 hours after initial administration of drug ]
    Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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) ]
  29. 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) ]
  30. 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) ]
  31. 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.

  32. 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.

  33. 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.



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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04061330


Contacts
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Contact: Paulina Sergot, MD (713) 500-7878 Paulina.B.Sergot@uth.tmc.edu
Contact: Misty Ottman 713-500-7870 Misty.Ottman@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Paulina Sergot, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Paulina Sergot, MD The University of Texas Health Science Center, Houston

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Responsible Party: Paulina Sergot, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04061330     History of Changes
Other Study ID Numbers: HSC-MS-19-0580
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Fractures, Bone
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Analgesics, Opioid
Morphine
Ketamine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action