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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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The goal of this pilot randomized clinical trial is to learn if oral ketamine intervention can control pain in emergency department patients whose providers feel the need for additional pain medication. The main questions it aims to answer are:
Researchers will compare oral ketamine to oral oxycodone to see if there is a difference in pain control or the need for additional opioid administration.
Participants will:
In an effort to combat the ongoing opioid crisis, healthcare providers continue to search for alternatives to opioids that are both safe and effective. While no medicine has an ideal profile, oral ketamine have attributes that may serve emergency department (ED) patients well when dealing with painful conditions. While IV ketamine has been well-studied in the ED setting and oral ketamine has been studied in the post-operative setting, there is limited data describing the safety and effectiveness of oral ketamine in the ED setting. Guided by colleagues from the Anesthesia Acute Pain Service, the Albany Medical Center (AMC) ED has begun giving oral ketamine to appropriate ED patients with painful conditions. We aim to conduct a pilot, un-blinded randomized controlled trial to compare the benefits and detriments of oral ketamine vs. oxycodone in ED patients who require 'second line' pain medicine.
A convenience sample of emergency department patients will be randomized to receive either:
Oxycodone arm:
o The treating provider will order oral oxycodone 5 mg times one
or
o The treating provider has made a deliberate decision that the patient requires (because of weight, prior exposures, etc.) greater than oxycodone 5mg times one
Oral ketamine arm:
o The treating provider will order ketamine 0.75 mg/kg oral times one (max 80mg)
Outcomes measured
Participants will be assessed for
We will calculate a difference in change in mean pain scores before and after the intervention in each study arm. We will also compare morphine milli-equivalents use during the time intervals above, as well as usage of opioids, ketamine, and recreational drugs during the one month and three month period after enrollment.
Because this is a pilot study, we have not calculated an effect size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral ketamine | Experimental | The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication. |
|
| oxycodone | Active Comparator | The oxycodone arm will receive a dose of oxycodone as a second line pain medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral ketamine | Drug | A dose of oral ketamine administered as a second line pain management medicine in the emergency department. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean pain score | This reflects the mean difference between the pain scores before and after the intervention. | This will be assessed at 30 minutes and 60 minutes after receiving the study drugs. |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of morphine in the following 24 hours. | Usage of morphine in the following 24 hours. | 24 hours |
| Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center Emergency Department | Albany | New York | 12208 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| oxycodone | Drug | A dose of oxycodone administered as a second line pain management medicine in the emergency department. |
|
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
| 1 month and 3 months after study enrollment. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003061 | Codeine |
| 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 |