Nasal Naloxone for Narcotic Overdose
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 236
- Locations
- 3
- Primary Endpoint
- Proportion of patients with adequate respiration within 10 minutes
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intranasal (IN) naloxone
Intranasal (IN) naloxone as initial response to suspected opioid overdose
Intervention: Intranasal (IN) naloxone (Drug)
Standard of Care (TAU)
Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose.
Intervention: Intravenous (IV) naloxone (Drug)
Standard of Care (TAU)
Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose.
Intervention: Intramuscular (IM) naloxone (Drug)
Standard of Care (TAU)
Standard of care (intravenous [IV], intramuscular [IM] or intraosseus [IO]delivery of naloxone) as initial response to suspected opioid overdose.
Intervention: Intraosseus (IO) naloxone (Drug)
Outcomes
Primary Outcomes
Proportion of patients with adequate respiration within 10 minutes
Time Frame: 10 minutes after intervention administration
Secondary Outcomes
- Number of patients requiring second dose of naloxone(within 10 minutes of initial dose)
- Time to first naloxone administration(at baseline)
- 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)
Investigators
Judith Feinberg
Assoc Chair of Medicine
University of Cincinnati