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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04061330
• Other study ID #: HSC-MS-19-0580
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Fractures, Bone
• Pain, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	5 minutes after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	10 minutes after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	30 minutes after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	60 minutes after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	2 hours after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	3 hours after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	4 hours after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	5 hours after initial administration of drug
Secondary	Number of hypotension episodes	Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg	6 hours after initial administration of drug
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)