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| ID | Type | Description | Link |
|---|---|---|---|
| Ohio Division of EMS Board | Other Grant/Funding Number | Ohio Department of Public Safety |
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The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.
This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous [IV], intramuscular [IM] or intraosseus [IO] delivery) versus intranasal [IN] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal (IN) naloxone | Experimental | Intranasal (IN) naloxone as initial response to suspected opioid overdose |
|
| Standard of Care (TAU) | Active Comparator | Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal (IN) naloxone | Drug |
|
| |
| Intravenous (IV) naloxone |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with adequate respiration within 10 minutes | 10 minutes after intervention administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients requiring second dose of naloxone | within 10 minutes of initial dose | |
| Time to first naloxone administration | Time between emergency call and administration of naloxone. | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Feinberg, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont County | Batavia | Ohio | United States |
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| D007273 | Injections, Intramuscular |
| D018538 | Jupiter |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
|
| Intramuscular (IM) naloxone | Drug |
|
|
| Intraosseus (IO) naloxone | Drug |
|
|
| Opioid Withdrawal Symptoms | baseline |
| Naloxone Adverse Events | 3 hours |
| Proportion of Patients breathing unassisted upon arrival to the hospital | within 1 hour |
| Days of hospitalization following naloxone administration | 7 days |
| Mortality rate | 7 days |
| Scioto County | Portsmouth | Ohio | United States |
|
| Adams County | West Union | Ohio | United States |
|
| D001523 | Mental Disorders |
| 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 |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D016083 | Planets |
| D016082 | Solar System |
| D055587 | Astronomical Objects |
| D055580 | Astronomical Phenomena |
| D055585 | Physical Phenomena |