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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Morphinan Opioid Overdose

Treatments: Drug: Intranasal naloxone; Drug: Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT01293058

ASD-1213-16

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intravenous

Other group

Description:

The investigators administered intravenous naloxone for our opioid overdose patients

Treatment:

Drug: Intravenous

Intranasal

Other group

Description:

The investigators administered intranasal naloxone for treatment of our patients

Treatment:

Drug: Intranasal naloxone