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.

Intervention / Treatment

  • Ketamine (DRUG)
    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.
  • Morphine (DRUG)
    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.

Condition or Disease

  • Pain, Acute

Phase

  • Phase 2
  • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 64 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jan 01, 2022 ESTIMATED
    Primary Completion: Dec 31, 2022 ESTIMATED
    Completion Date: Dec 31, 2022 ESTIMATED
    Study First Posted: Aug 19, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 19, 2022

    Sponsors / Collaborators

    Responsible Party: N/A

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 64
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    • The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    Secondary Outcomes
    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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 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 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 from time of initial administration of drug to 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 will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.

    • Nursing satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.

    More Details

    NCT Number: NCT04061330
    Other IDs: HSC-MS-19-0580
    Study URL: https://clinicaltrials.gov/study/NCT04061330
    Last updated: Sep 29, 2023