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The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department.
The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.
The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals |
|
| Placebo | Placebo Comparator | Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes | Change from Baseline of Pain as described by Numeric Rating Scale (NRS) [minimum:0, maximum 10] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes. | 15 minutes after administration of study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Incidence or number of participants with adverse events. | during the study period |
| Patient Satisfaction of Pain Control Based on a Likert Scale | Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Billy Sin, Pharm.D. | The Brooklyn Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brooklyn Hospital Center | Brooklyn | New York | 11201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17499654 | Background | Galinski M, Dolveck F, Combes X, Limoges V, Smail N, Pommier V, Templier F, Catineau J, Lapostolle F, Adnet F. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007 May;25(4):385-90. doi: 10.1016/j.ajem.2006.11.016. | |
| 8669651 | Background | Gurnani A, Sharma PK, Rautela RS, Bhattacharya A. Analgesia for acute musculoskeletal trauma: low-dose subcutaneous infusion of ketamine. Anaesth Intensive Care. 1996 Feb;24(1):32-6. doi: 10.1177/0310057X9602400106. |
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This was a single-center, prospective, randomized, double-blind, placebo-controlled trial comparing the use of SDDK versus placebo as an adjunct therapy for moderate to severe acute pain in the ED. The study was conducted in a community teaching hospital with a level-2 trauma ED where more than 77,000 patients are treated annually.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes |
| FG001 | Placebo | Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals Placebo: Normal saline 50ml, administered over 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes | Change from Baseline of Pain as described by Numeric Rating Scale (NRS) [minimum:0, maximum 10] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes. | Posted | Median | Inter-Quartile Range | units on a scale | 15 minutes after administration of study intervention |
|
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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 | Treatment | Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dreams | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Emergency Medicine Clinical Research Program | The Brooklyn Hospital Center | 718-250-6250 | bsin@tbh.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo |
| Drug |
Normal saline 50ml, administered over 15 minutes |
|
| At the end of study period |
| Mean Consumption of Rescue Analgesia | at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes) |
| ED Length of Stay (Minutes) | ED Length of stay (minutes) throughout study period | throughout study completion |
| 23560967 | Background | Yeaman F, Oakley E, Meek R, Graudins A. Sub-dissociative dose intranasal ketamine for limb injury pain in children in the emergency department: a pilot study. Emerg Med Australas. 2013 Apr;25(2):161-7. doi: 10.1111/1742-6723.12059. Epub 2013 Mar 20. |
| 24712757 | Background | Yeaman F, Meek R, Egerton-Warburton D, Rosengarten P, Graudins A. Sub-dissociative-dose intranasal ketamine for moderate to severe pain in adult emergency department patients. Emerg Med Australas. 2014 Jun;26(3):237-42. doi: 10.1111/1742-6723.12173. Epub 2014 Apr 8. |
| 23602757 | Background | Ahern TL, Herring AA, Stone MB, Frazee BW. Effective analgesia with low-dose ketamine and reduced dose hydromorphone in ED patients with severe pain. Am J Emerg Med. 2013 May;31(5):847-51. doi: 10.1016/j.ajem.2013.02.008. Epub 2013 Apr 18. |
| 24127709 | Background | Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229. |
Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Adverse Events | Incidence or number of participants with adverse events. | Nausea was reported in three patients who received placebo and one patient who received ketamine. Dreams was reported in 1 patient who received placebo and one patient who received ketamine. | Posted | Number | participants | during the study period |
|
|
|
| Secondary | Patient Satisfaction of Pain Control Based on a Likert Scale | Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied. | Posted | Mean | Standard Deviation | units on a scale | At the end of study period |
|
|
|
| Secondary | Mean Consumption of Rescue Analgesia | Posted | Mean | Standard Deviation | milligrams | at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes) |
|
|
|
| Secondary | ED Length of Stay (Minutes) | ED Length of stay (minutes) throughout study period | Posted | Mean | Standard Deviation | minutes | throughout study completion |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Placebo | Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals | 0 | 30 | 0 | 30 | 4 | 30 |
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea |
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| T30 |
|
| T45 |
|
| T60 |
|
| T75 |
|
| T90 |
|
| T105 |
|
| T120 |
|