Back to resultsRandomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
Primary Purpose
Morphinan Opioid Overdose
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intranasal naloxone
Intravenous
Sponsored by
About this trial
This is an interventional treatment trial for Morphinan Opioid Overdose focused on measuring opioid, overdose, naloxone, intranasal
Eligibility Criteria
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
Sites / Locations
- Noor university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intravenous
Intranasal
Arm Description
The investigators administered intravenous naloxone for our opioid overdose patients
The investigators administered intranasal naloxone for treatment of our patients
Outcomes
Primary Outcome Measures
level of consciousness
The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration
Secondary Outcome Measures
blood pressure
The investigators evaluated blood pressure 4 minutes after naloxone administration
Full Information
NCT ID
NCT01293058
First Posted
February 9, 2011
Last Updated
February 9, 2011
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01293058
Brief Title
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
Official Title
Study of Routs of Naloxone Administration for Opioid Overdosed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morphinan Opioid Overdose
Keywords
opioid, overdose, naloxone, intranasal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous
Arm Type
Other
Arm Description
The investigators administered intravenous naloxone for our opioid overdose patients
Arm Title
Intranasal
Arm Type
Other
Arm Description
The investigators administered intranasal naloxone for treatment of our patients
Intervention Type
Drug
Intervention Name(s)
Intranasal naloxone
Intervention Description
spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness
Intervention Type
Drug
Intervention Name(s)
Intravenous
Intervention Description
Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
Primary Outcome Measure Information:
Title
level of consciousness
Description
The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration
Time Frame
4 min after naloxone administration
Secondary Outcome Measure Information:
Title
blood pressure
Description
The investigators evaluated blood pressure 4 minutes after naloxone administration
Time Frame
at 4 min after naloxone administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nastaran Izadi, A.Professor
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noor university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://mui.ac.ir
Description
Isfahan university of medical sciences
Learn more about this trial
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
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