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

Isfahan University of Medical Sciences100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Morphinan Opioid Overdose

Interventions

Intranasal naloxoneDRUG

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

IntravenousDRUG

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Noor university hospital

Isfahan, Isfahan, Iran

Outcomes

Primary Outcomes

level of consciousness

The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration

Time frame: 4 min after naloxone administration

Secondary Outcomes

blood pressure

The investigators evaluated blood pressure 4 minutes after naloxone administration

Time frame: at 4 min after naloxone administration

Data from ClinicalTrials.gov

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