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

Morphinan Opioid Overdose Clinical Trial

Official title:

Study of Routs of Naloxone Administration for Opioid Overdosed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293058
• Other study ID #: ASD-1213-16
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2011
• Last updated: February 9, 2011
• Start date: March 2007
• Est. completion date: June 2007

Study information

• Verified date: March 2007
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Overdose
• Morphinan Opioid Overdose

Intervention

Drug:
• Intranasal naloxone
spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness
• Intravenous
Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness

Locations

Country	Name	City	State
Iran, Islamic Republic of	Noor university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of consciousness	The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration	4 min after naloxone administration	Yes
Secondary	blood pressure	The investigators evaluated blood pressure 4 minutes after naloxone administration	at 4 min after naloxone administration	Yes

External Links

•   Isfahan university of medical sciences