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

February 9, 2011 updated by: Isfahan University of Medical Sciences

Study of Routs of Naloxone Administration for Opioid Overdosed Patients

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

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intravenous
The investigators administered intravenous naloxone for our opioid overdose patients
Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
Other: Intranasal
The investigators administered intranasal naloxone for treatment of our patients
spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of consciousness
Time Frame: 4 min after naloxone administration
The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration
4 min after naloxone administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: at 4 min after naloxone administration
The investigators evaluated blood pressure 4 minutes after naloxone administration
at 4 min after naloxone administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nastaran Izadi, A.Professor, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

February 10, 2011

Last Update Submitted That Met QC Criteria

February 9, 2011

Last Verified

March 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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