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| Name | Class |
|---|---|
| U.S. Air Force Office of the Surgeon General | FED |
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The purpose of this study is to compare the safety and effectiveness of intravenous low dose ketamine (LDK) to the industry standard of morphine (MOR) in regards to controlling acute pain in the emergency department.
Both LDK and morphine have side effects. The amount and character of these side effects will be compared. Additionally, the degree of sedation or agitation will be specifically measured. The aim of this current study is to make this comparison and shift the evidence for LDK use from the anecdotal to the scientific.
Phase 1 is a randomized, controlled, double-blinded study comparing the use of low-dose ketamine (LDK) to morphine for acute pain control in emergency department patients. A convenience sample of subjects will be enrolled from a population of patients aged 18-50 who present to the Brooke Army Medical Center Emergency Department with acute abdominal pain, flank/lumbar back pain and/or pain to the extremities. To take part in the study, a need for opioid analgesia must be indicated by the treating physician in addition to the patient meeting all other study criteria.
The patient will then be randomized into one of the two treatment arms. Prior to receiving either the study medication (ketamine) or the active control (morphine) the patient will be asked to rate their pain on a numeric rating scale (NRS) with 0 being no pain and 10 being the worst pain possible. Their baseline vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) will also be documented. These vital signs and the NRS will be reassessed at 5, 10 and 20 minutes post medication dosage. At 20 minutes they will also document a Richmond Agitation Sedation Scale (RASS) score and will ask the patient if they require additional pain medication. If the patient denies the need for a second dose of medication they will continue to be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing.
If at any time during the study the patient requires a second dose of pain medication, following the administration of the med, they will be assessed for vital signs at 5,10 and 20 minutes after the dose. At 20 minutes, a RASS score and NRS score will also be documented. They will then be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing.
If they require a third dose of pain medication at any time during the study, this is considered a treatment failure and the treating physician will be contacted to provide any further pain control.
The second phase of the study will be observational. An anonymous satisfaction survey will be provided to the treating nurse, physician or physicians assistant (PA) of the patients recruited from part one of the study. The purpose of conducting the survey is so that an observation point of view can be added to the data to provide a measure of how well the patient's pain was controlled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | 0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. |
|
| Morphine | Active Comparator | 0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 0.3 mg/kg ketamine Intravenous push (IVP) over 5 minutes. Total of two possible doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score | Numerical Rating Scale (NRS) pain score is an 11-point rating scale for pain. With 0 being no pain and 10 being the worst pain imaginable. | 5,10,20,40,60,80,100,120 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Change in NRS Pain Score | Following dosage with study medication, the amount of time taken to demonstrate a change in the patient's NRS pain score. Time to Change in NRS Pain Score for the Reporting Group as a whole will be made | 5,10, 20,40,60,80,100,120 minutes |
| Time to Maximal Change in NRS Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua P Miller, MD | United States Air Force | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
Patients were excluded if: O2 saturation <95%, SBP < 90mmHg or > 180mmHg, HR< 50 or > 120 beats per minute, RR < 10 or > 30 per minute, altered mental status, intoxication, history fibromyalgia, ischemic heart disease, heart failure or unstable dysrhythmias, required pain medication immediately and cannot wait to consent
The study took place at a Level 1 trauma center. The patient population at SAMMC consists of active duty military personnel and their family members, retirees, as well as civilians. There are approximately 75,000 visits to the SAMMC ED annually. Enrollment occurred from February 2012 to March 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | 0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses. |
| FG001 | Morphine | 0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | 0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses. |
| BG001 | Morphine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score | Numerical Rating Scale (NRS) pain score is an 11-point rating scale for pain. With 0 being no pain and 10 being the worst pain imaginable. | Posted | Mean | 95% Confidence Interval | NRS pain scale score | 5,10,20,40,60,80,100,120 minutes post dose | units on a scale | units on a scale |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | 0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses. |
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The side effect profile associated with ketamine and morphine are different without significant overlap thus making blinding difficult.
The exclusion criteria of our study made enrollment difficult and our sample size smaller than anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josh Miller | SAUSHEC | 210-916-7111 | joshmillersr@gmail.com |
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| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| D021501 | Flank Pain |
| D001416 | Back Pain |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Morphine | Drug | 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses. |
|
|
Following dosage with study medication, the interval time taken to demonstrate the maximal change in the patient's NRS pain score will be reported for each group. |
| 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes |
| Incidence of Treatment Failure | Requiring more than two doses of the study medication provided for adequate pain control | 120 minutes |
| Incidence of Side Effects, Including Outlying Vital Signs | The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), and all side effects at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. All side effects and outlying vital signs will be documented. | 5,10,20,40,60,80,100,120 minutes |
| Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS) | Using 0 as the "normal/baseline" on the RASS, maximal deviation in either direction will be used to demonstrate the effect of the study medications on levels of sedation or agitation. Results will be reported as Richmond Agitation Sedation Scale (RASS) scores range from:
| 5,10,20,40,60,80,100,120 minutes |
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.
Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Change in NRS Pain Score | Following dosage with study medication, the amount of time taken to demonstrate a change in the patient's NRS pain score. Time to Change in NRS Pain Score for the Reporting Group as a whole will be made | Posted | Mean | Standard Deviation | minutes | 5,10, 20,40,60,80,100,120 minutes |
|
|
|
| Secondary | Time to Maximal Change in NRS Pain Score | Following dosage with study medication, the interval time taken to demonstrate the maximal change in the patient's NRS pain score will be reported for each group. | Posted | Median | Standard Deviation | minutes | 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes |
|
|
|
| Secondary | Incidence of Treatment Failure | Requiring more than two doses of the study medication provided for adequate pain control | Posted | Number | Percentage of patients | 120 minutes |
|
|
|
| Secondary | Incidence of Side Effects, Including Outlying Vital Signs | The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), and all side effects at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. All side effects and outlying vital signs will be documented. | Posted | Number | Percentage of patients | 5,10,20,40,60,80,100,120 minutes |
|
|
|
| Secondary | Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS) | Using 0 as the "normal/baseline" on the RASS, maximal deviation in either direction will be used to demonstrate the effect of the study medications on levels of sedation or agitation. Results will be reported as Richmond Agitation Sedation Scale (RASS) scores range from:
| Posted | Mean | Full Range | units on a scale | 5,10,20,40,60,80,100,120 minutes |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Morphine | 0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses. | 0 | 21 | 0 | 21 |
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| D012817 | Signs and Symptoms, Digestive |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |