Not provided
Not provided
Not provided
Not provided
Not provided
concern of side effects
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American College of Emergency Physicians | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine and placebo | Active Comparator | 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 |
|
| Morphine and Ketamine | Experimental | Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 0.3mg/kg ketamine |
| |
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Score | Pain 0-10 with 0 being no pain and 10 being the worst pain | Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Morphine and Other Pain Medications Administered | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) | |
| Number of Participants With Adverse Events | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Health Network University Campus 1501 North Campbell Ave | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Morphine and Placebo | 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 Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine |
| FG001 | Morphine and Ketamine | Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Morphine and Placebo | 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 Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Numeric Pain Score | Pain 0-10 with 0 being no pain and 10 being the worst pain | Posted | Mean | Standard Deviation | score on a scale | Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Morphine and Placebo | 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 Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe dysphoric reaction | Psychiatric disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaiva Larsen | University of Arizona | 5039396612 | jlarsen@aemrc.arizona.edu |
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Dosage of morphine determined by treating physician |
|
| placebo | Drug | saline of same volume as appropriate weight based dose of ketamine |
|
| BG001 |
| Morphine and Ketamine |
Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Total Amount of Morphine and Other Pain Medications Administered | Posted | Mean | Standard Deviation | mg | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) |
|
|
|
| Secondary | Number of Participants With Adverse Events | Posted | Count of Participants | Participants | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Morphine and Ketamine | Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician | 0 | 7 | 0 | 7 | 4 | 7 |
| adverse event not specified | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| 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 |