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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 hours after initial administration of drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 5 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 10 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 30 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 60 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 2 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 3 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 4 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 5 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 hours after initial administration of drug
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
Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Time frame: 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.
Time frame: 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.
Time frame: end of treatment (about 6 hours after initial administration of drug)