The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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
Intervention / Treatment
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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.
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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
Study Design
Study type: | INTERVENTIONAL |
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Status: | Withdrawn |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 |
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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
Location
Participant Groups
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No description provided
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No description provided
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 64 |
Age Groups: | Adult |
Healthy Volunteers: | Yes |
* 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
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
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The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Secondary Outcomes
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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)
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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)
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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)
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Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
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Physician satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
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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 |
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Other IDs: | HSC-MS-19-0580 |
Study URL: | https://clinicaltrials.gov/study/NCT04061330 |