Skip to content

Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose

Study of Routs of Naloxone Administration for Opioid Overdosed Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01293058
Enrollment
100
Registered
2011-02-10
Start date
2007-03-31
Completion date
2007-06-30
Last updated
2011-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morphinan Opioid Overdose

Keywords

opioid, overdose, naloxone, intranasal

Brief summary

The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients

Detailed description

In intravenous drug abusers (IDUs), as a result of previous intravenous substance abuse, the predictable difficult cannulate exist and cause the delay administration of antidote therapy. Additionally, IDUs are also at increased risk of carrying blood borne infections that could be transmitted to healthcare workers through needle stick injuries. The investigators aimed to compare intranasal administration of naloxone with intravenous route.

Interventions

spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness

Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with the range of 15-50 years old * Who were suspicious to opioid overdoses based on history and having clinical appearance such as miotic pupils with loss of consciousness * Give response to naloxone with increasing the level of consciousness

Exclusion criteria

* Not giving response to naloxone and suspicious to have another reason for loss of consciousness

Design outcomes

Primary

MeasureTime frameDescription
level of consciousness4 min after naloxone administrationThe investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration

Secondary

MeasureTime frameDescription
blood pressureat 4 min after naloxone administrationThe investigators evaluated blood pressure 4 minutes after naloxone administration

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026