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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Morphinan Opioid Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intravenous

The investigators administered intravenous naloxone for our opioid overdose patients

Group Type OTHER

Intravenous

Intervention Type DRUG

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

Intranasal

The investigators administered intranasal naloxone for treatment of our patients

Group Type OTHER

Intranasal naloxone

Intervention Type DRUG

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

Interventions

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Intranasal naloxone

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

Intervention Type DRUG

Intravenous

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

Intervention Type DRUG

Eligibility Criteria

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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