- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04061330
Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
April 19, 2022 updated by: Paulina Sergot, The University of Texas Health Science Center, Houston
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
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine Group
|
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
|
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)
Time Frame: baseline
|
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)
Time Frame: 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.
|
5 minutes after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
10 minutes after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
30 minutes after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
60 minutes after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
2 hours after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
3 hours after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
4 hours after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
5 hours after initial administration of drug
|
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time Frame: 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.
|
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
Time Frame: 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.
|
5 minutes after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
10 minutes after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
30 minutes after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
60 minutes after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
2 hours after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
3 hours after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
4 hours after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
5 hours after initial administration of drug
|
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time Frame: 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.
|
6 hours after initial administration of drug
|
Number of hypotension episodes
Time Frame: 5 minutes after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
5 minutes after initial administration of drug
|
Number of hypotension episodes
Time Frame: 10 minutes after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
10 minutes after initial administration of drug
|
Number of hypotension episodes
Time Frame: 30 minutes after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
30 minutes after initial administration of drug
|
Number of hypotension episodes
Time Frame: 60 minutes after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
60 minutes after initial administration of drug
|
Number of hypotension episodes
Time Frame: 2 hours after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
2 hours after initial administration of drug
|
Number of hypotension episodes
Time Frame: 3 hours after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
3 hours after initial administration of drug
|
Number of hypotension episodes
Time Frame: 4 hours after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
4 hours after initial administration of drug
|
Number of hypotension episodes
Time Frame: 5 hours after initial administration of drug
|
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
|
5 hours after initial administration of drug
|
Number of hypotension episodes
Time Frame: 6 hours after initial administration of drug
|
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)
Time Frame: 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.
|
5 minutes after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
10 minutes after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
30 minutes after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
60 minutes after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
2 hours after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
3 hours after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
4 hours after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
5 hours after initial administration of drug
|
Score on Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
|
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)
|
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)
|
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)
|
from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
|
|
Patient satisfaction with analgesia
Time Frame: 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.
|
end of treatment (about 6 hours after initial administration of drug)
|
Physician satisfaction with analgesia
Time Frame: 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.
|
end of treatment (about 6 hours after initial administration of drug)
|
Nursing satisfaction with analgesia
Time Frame: 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.
|
end of treatment (about 6 hours after initial administration of drug)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paulina Sergot, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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