Clinical Trial: Nasal Naloxone for Narcotic Overdose

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Nasal Naloxone for Narcotic Overdose

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 Summary: 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.
Sponsor: Judith Feinberg

Current Primary Outcome: Proportion of patients with adequate respiration within 10 minutes [ Time Frame: 10 minutes after intervention administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients requiring second dose of naloxone [ Time Frame: within 10 minutes of initial dose ]
  • Time to first naloxone administration [ Time Frame: at baseline ]
    Time between emergency call and administration of naloxone.
  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: July 29, 2013
Date Started: September 2013
Date Completion: March 2015
Last Updated: July 29, 2013
Last Verified: July 2013