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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000322538

Enrollment

200

Registered

2006-07-26

Start date

2006-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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-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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

All suspected opiate overdose victims in the prehospital setting to be treated by paramedics with naloxone will be included in this study, regardless of age or gender .Client unrousable i.e. GCS less than 13.No major facial trauma/blocked nasal passages/epistaxis.

Exclusion criteria

Client rousable i.e. GCS Greater than 12.Major facial trauma/blocked nasal passages/epistaxis.

Outcome results