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

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 Overview

• Status: Withdrawn
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: Ketamine; Drug: Morphine

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine Group	Drug: Ketamine; 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.
Active Comparator: Opioid group	Drug: Morphine; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Paulina Sergot, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Emergencies; Fractures, Bone; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Morphine
• Other Study ID Numbers: HSC-MS-19-0580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No