- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293058
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
Conditions
Intervention / Treatment
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
-
-
-
Isfahan, Iran, Islamic Republic of
- Noor university hospital
-
-
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.
Helpful Links
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASD-1213-16
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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