Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department
Primary Purpose
Acute Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Morphine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Ketamine, Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Presenting to Emergency Department in acute pain
- age 18 and over
- determined to require morphine for pain control by treating physician
Exclusion Criteria:
- Patients presenting with headache or head injury
- Patient with eye injury or eye pain
- Nontraumatic chest Pain
- Pregnant patients or women of childbearing potential
- Patients allergic to morphine or ketamine
- Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill
- Patients with hypertension: diastolic blood pressure > 100 OR systolic blood pressure > 180
- Patient whose pain is so severe that they are unable to give informed consent
- Patients who have had bad experiences to prior hallucinations from any origin
Sites / Locations
- University of Arizona Health Network University Campus 1501 North Campbell Ave
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Morphine and placebo
Morphine and Ketamine
Arm Description
Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy
Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care
Outcomes
Primary Outcome Measures
Numeric Pain Score
Pain 0-10 with 0 being no pain and 10 being the worst pain
Secondary Outcome Measures
Total Amount of Morphine and Other Pain Medications Administered
Number of Participants With Adverse Events
Full Information
NCT ID
NCT01900847
First Posted
July 8, 2013
Last Updated
July 11, 2023
Sponsor
University of Arizona
Collaborators
Arizona College of Emergency Physicians
1. Study Identification
Unique Protocol Identification Number
NCT01900847
Brief Title
Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department
Official Title
Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
concern of side effects
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
April 1, 2014 (Actual)
Study Completion Date
April 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Arizona College of Emergency Physicians
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department.
Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Ketamine, Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine and placebo
Arm Type
Active Comparator
Arm Description
Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy
Arm Title
Morphine and Ketamine
Arm Type
Experimental
Arm Description
Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
0.3mg/kg ketamine
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Dosage of morphine determined by treating physician
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
saline of same volume as appropriate weight based dose of ketamine
Primary Outcome Measure Information:
Title
Numeric Pain Score
Description
Pain 0-10 with 0 being no pain and 10 being the worst pain
Time Frame
Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug
Secondary Outcome Measure Information:
Title
Total Amount of Morphine and Other Pain Medications Administered
Time Frame
Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Title
Number of Participants With Adverse Events
Time Frame
Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presenting to Emergency Department in acute pain
age 18 and over
determined to require morphine for pain control by treating physician
Exclusion Criteria:
Patients presenting with headache or head injury
Patient with eye injury or eye pain
Nontraumatic chest Pain
Pregnant patients or women of childbearing potential
Patients allergic to morphine or ketamine
Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill
Patients with hypertension: diastolic blood pressure > 100 OR systolic blood pressure > 180
Patient whose pain is so severe that they are unable to give informed consent
Patients who have had bad experiences to prior hallucinations from any origin
Facility Information:
Facility Name
University of Arizona Health Network University Campus 1501 North Campbell Ave
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Berkman, M. R., Larsen, J., Smith, J., Caldwell, J., Waterbrook, A., Stolz, U., & Denninghoff, K. (2014). 369 Ketamine and Morphine versus Morphine Alone for Treatment of Acute Pain in the Emergency Department. Annals of Emergency Medicine, 64(4), S131-S132.
Results Reference
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Learn more about this trial
Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department
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