Drug Overdose
Conditions
Keywords
heroin, prescription pain killers, narcotics
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.
Interventions
DRUGIntranasal (IN) naloxone
DRUGIntraosseus (IO) naloxone
Sponsors
Judith Feinberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with adequate respiration within 10 minutes | 10 minutes after intervention administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first naloxone administration | at baseline | Time between emergency call and administration of naloxone. |
| Opioid Withdrawal Symptoms | baseline | — |
| Naloxone Adverse Events | 3 hours | — |
| Number of patients requiring second dose of naloxone | within 10 minutes of initial dose | — |
| Days of hospitalization following naloxone administration | 7 days | — |
| Mortality rate | 7 days | — |
| Proportion of Patients breathing unassisted upon arrival to the hospital | within 1 hour | — |
Countries
United States
Outcome results
None listed