Nasal Naloxone for Narcotic Overdose
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Overdose
Intervention: Intranasal (IN) naloxone (Drug); Intravenous (IV) naloxone (Drug); Intramuscular (IM) naloxone (Drug); Intraosseus (IO) naloxone (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Judith Feinberg Official(s) and/or principal investigator(s): Judith Feinberg, MD, Principal Investigator, Affiliation: University of Cincinnati
Summary
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.
Clinical Details
Official title: Nasal Naloxone for Narcotic Overdose
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of patients with adequate respiration within 10 minutes
Secondary outcome: Number of patients requiring second dose of naloxoneTime to first naloxone administration Opioid Withdrawal Symptoms Naloxone Adverse Events Proportion of Patients breathing unassisted upon arrival to the hospital Days of hospitalization following naloxone administration Mortality rate
Detailed description:
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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Presence of hyperventilation or respiratory arrest OR
- EMS assessment that the person needs naloxone for possible opioid or unknown drug
overdose
Exclusion Criteria:
- EMS assessment that the participant is less than 12 years old
Locations and Contacts
Clermont County, Batavia, Ohio, United States; Not yet recruiting Joe Renusch, MD
Scioto County, Portsmouth, Ohio, United States; Not yet recruiting Brian Barhorst, MD
Adams County, West Union, Ohio, United States; Not yet recruiting Bruce Ashley, MD
Additional Information
Starting date: September 2013
Last updated: July 29, 2013
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