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

Primary Outcomes

• Clinical pain as assessed by the Numerical pain rating score (NPRS) baseline

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

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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.

• Clinical pain as assessed by the Numerical pain rating score (NPRS) 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 Outcomes

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypoxic episodes as measured with a continuous pulse oximeter 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.

• Number of hypotension episodes 5 minutes after initial administration of drug

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

• Number of hypotension episodes 10 minutes after initial administration of drug

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

• Number of hypotension episodes 30 minutes after initial administration of drug

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

• Number of hypotension episodes 60 minutes after initial administration of drug

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

• Number of hypotension episodes 2 hours after initial administration of drug

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

• Number of hypotension episodes 3 hours after initial administration of drug

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

• Number of hypotension episodes 4 hours after initial administration of drug

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

• Number of hypotension episodes 5 hours after initial administration of drug

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

• Number of hypotension episodes 6 hours after initial administration of drug

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

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• Score on Richmond Agitation-Sedation Scale (RASS) 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.

• 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 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 with analgesia 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.

• Nursing satisfaction with analgesia 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.