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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Clermont County
Batavia, Ohio, United States
Scioto County
Portsmouth, Ohio, United States
Adams County
West Union, Ohio, United States
Proportion of patients with adequate respiration within 10 minutes
Time frame: 10 minutes after intervention administration
Number of patients requiring second dose of naloxone
Time frame: within 10 minutes of initial dose
Time to first naloxone administration
Time between emergency call and administration of naloxone.
Time frame: at baseline
Opioid Withdrawal Symptoms
Time frame: baseline
Naloxone Adverse Events
Time frame: 3 hours
Proportion of Patients breathing unassisted upon arrival to the hospital
Time frame: within 1 hour
Days of hospitalization following naloxone administration
Time frame: 7 days
Mortality rate
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.