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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 Purpose

Pain, Acute

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Morphine
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine Group

Opioid group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of participants with need for rescue opioid therapy
Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria
Number of participants with Adverse reactions
Patient satisfaction with analgesia
Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Physician satisfaction with analgesia
Physician satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Nursing satisfaction with analgesia
Nursing satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.

Full Information

First Posted
August 15, 2019
Last Updated
April 19, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04061330
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study was terminated prior to enrollment due to lack of funding
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Group
Arm Type
Experimental
Arm Title
Opioid group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Time Frame
baseline
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Title
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Description
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
Secondary Outcome Measure Information:
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypoxic episodes as measured with a continuous pulse oximeter
Description
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
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
5 minutes after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
10 minutes after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
30 minutes after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
60 minutes after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
2 hours after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
3 hours after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
4 hours after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
5 hours after initial administration of drug
Title
Number of hypotension episodes
Description
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Time Frame
6 hours after initial administration of drug
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
Score on Richmond Agitation-Sedation Scale (RASS)
Description
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
Title
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)
Title
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)
Title
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)
Title
Patient satisfaction with analgesia
Description
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)
Title
Physician satisfaction with analgesia
Description
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)
Title
Nursing satisfaction with analgesia
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Sergot, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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