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Completed

NCT Number: NCT01293058

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

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

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Key information

Conditions

Morphinan Opioid Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Noor university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal naloxone

Drug

spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness

Intravenous

Drug

Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness

Primary outcomes

  1. level of consciousness

    Time frame: 4 min after naloxone administration

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

Secondary outcomes

  1. blood pressure

    Time frame: at 4 min after naloxone administration

    The investigators evaluated blood pressure 4 minutes after naloxone administration

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Routs of Naloxone Administration for Opioid Overdosed Patients

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 10, 2011
Registry last updated
Feb 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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