Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
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
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Purpose
The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients
| Condition | Intervention | Phase |
|---|---|---|
|
Morphinan Opioid Overdose |
Drug: Intranasal naloxone Drug: Intravenous |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study of Routs of Naloxone Administration for Opioid Overdosed Patients |
Resource links provided by NLM:
Further study details as provided by Isfahan University of Medical Sciences:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 100 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Intravenous
The investigators administered intravenous naloxone for our opioid overdose patients
|
Drug: Intravenous
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
|
Drug: Intranasal naloxone
spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293058
Locations
| Iran, Islamic Republic of | |
| Noor university hospital | |
| Isfahan, Iran, Islamic Republic of | |
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
| Principal Investigator: | Nastaran Izadi, A.Professor | Isfahan University of Medical Sciences |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01293058 History of Changes |
| Other Study ID Numbers: | ASD-1213-16 |
| Study First Received: | February 9, 2011 |
| Last Updated: | February 9, 2011 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Isfahan University of Medical Sciences:
|
opioid overdose naloxone intranasal |
Additional relevant MeSH terms:
|
Overdose Poisoning Substance-Related Disorders Naloxone Analgesics, Opioid Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 17, 2013