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

Phase 2

Completed

• Conditions: Morphinan Opioid Overdose
• Interventions: Drug: Intravenous; Drug: Intranasal naloxone

• Registration Number: NCT01293058
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Status Verified: 2007-03
• Study Start: 2007-03
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Last Update Submitted: 2011-02-09
• Study First Posted: 2011-02-10
• Last Update Posted: 2011-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous	Intravenous	The investigators administered intravenous naloxone for our opioid overdose patients
Intranasal	Intranasal naloxone	The investigators administered intranasal naloxone for treatment of our patients

Primary Outcome Measures

Name	Time	Method
level of consciousness	4 min after naloxone administration	The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration

Secondary Outcome Measures

Name	Time	Method
blood pressure	at 4 min after naloxone administration	The investigators evaluated blood pressure 4 minutes after naloxone administration

Trial Locations

Locations (1)

Noor university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of