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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Ketamine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine Group<br> | Drug: Ketamine<br>* 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.<br>|
| Active Comparator: Opioid group<br> | Drug: Morphine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | baseline | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 5 minutes after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 10 minutes after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 30 minutes after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 60 minutes after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 2 hours after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 3 hours after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 4 hours after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 5 hours after initial administration of drug | 
| Clinical pain as assessed by the Numerical pain rating score (NPRS) | The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain. | 6 hours after initial administration of drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoxic episodes as measured with 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. | 5 minutes after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 10 minutes after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 30 minutes after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 60 minutes after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 2 hours after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 3 hours after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 4 hours after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 5 hours after initial administration of drug | 
| Number of hypoxic episodes as measured with 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. | 6 hours after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 5 minutes after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 10 minutes after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 30 minutes after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 60 minutes after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 2 hours after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 3 hours after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 4 hours after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 5 hours after initial administration of drug | 
| Number of hypotension episodes | Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg | 6 hours after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 5 minutes after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 10 minutes after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 30 minutes after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 60 minutes after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 2 hours after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 3 hours after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 4 hours after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 5 hours after initial administration of drug | 
| Score on Richmond Agitation-Sedation Scale (RASS) | 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. | 6 hours after initial administration of drug | 
| 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 with analgesia | Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied. | end of treatment (about 6 hours after initial administration of drug) | 
| Physician satisfaction with analgesia | Physician satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied. | end of treatment (about 6 hours after initial administration of drug) | 
| Nursing satisfaction with analgesia | Nursing satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied. | end of treatment (about 6 hours after initial administration of drug) |