CompletedPhase 4ACTRN12606000322538

The efficacy of intranasal administration of Naloxone by paramedics for the successful treatment of suspected heroin overdose in the prehospital setting.


Sponsor

Department of Human Services, Australian Government.

Enrollment

200 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions

Summary

The purpose of this study is to determine the effectiveness of concentrated intranasal naloxone compared to intramuscular naloxone for treatment by paramedics of respiratory depression due to suspected opiate overdose in the pre-hospital setting. Subjects are unconscious prior to study enrolment, and consent from individuals for study participation is not required.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study compares giving the overdose-reversal drug naloxone as a nasal spray versus the standard injection method when paramedics treat suspected heroin overdoses in the field. It is open to all ages and genders, as long as the person is unresponsive and does not have major facial injuries or blocked nasal passages.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Randomisation to receive either intramuscular naloxone 2mg or intranasal naloxone 2mg via a mucosal atomisation device [MAD]. Subjects receive one dose only of intranasal naloxone before re-assessmen

Randomisation to receive either intramuscular naloxone 2mg or intranasal naloxone 2mg via a mucosal atomisation device [MAD]. Subjects receive one dose only of intranasal naloxone before re-assessment at 10 minutes post treatment. Subjects are given additional intramuscular Naloxone after 10 minutes if clinically necessary. Duration of the study is likely to be 18 months, commencing 1st August 2006 and concluding 31st January 2008.


Locations(1)

Australia

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ACTRN12606000322538


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