Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01293058
First received: February 9, 2011
Last updated: NA
Last verified: March 2007
History: No changes posted

February 9, 2011
February 9, 2011
March 2007
June 2007   (final data collection date for primary outcome measure)
level of consciousness [ Time Frame: 4 min after naloxone administration ] [ Designated as safety issue: Yes ]
The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration
Same as current
No Changes Posted
blood pressure [ Time Frame: at 4 min after naloxone administration ] [ Designated as safety issue: Yes ]
The investigators evaluated blood pressure 4 minutes after naloxone administration
Same as current
Not Provided
Not Provided
 
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Morphinan Opioid Overdose
  • Drug: Intranasal naloxone
    spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness
  • Drug: Intravenous
    Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
  • Intravenous
    The investigators administered intravenous naloxone for our opioid overdose patients
    Intervention: Drug: Intravenous
  • Intranasal
    The investigators administered intranasal naloxone for treatment of our patients
    Intervention: Drug: Intranasal naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
15 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01293058
ASD-1213-16
Yes
Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Principal Investigator: Nastaran Izadi, A.Professor Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP