Randomised, double-blinded clinical trial comparing intranasal and intramuscular naloxone for suspected opioid overdose
Phase 2
Completed
- Conditions
- Suspected acute opioid overdosePublic Health - Other public health
- Registration Number
- ACTRN12611000852954
- Lead Sponsor
- Sydney Medically Supervised Injecting Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
All clients with symptoms/signs of an opioid overdose requiring Naloxone administration will be eligible for entry. This is based on existing and approved MSIC protocols and clinical criteria for overdose (reduced level of consciousness as measured by the Glasgow Coma Score, pinpoint pupils, respiratory depression and/or reduced oxygen saturations as measured by pulse oximetry).
Exclusion Criteria
Less than 18 years of age
Pregnant or suspected of being pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o requirement of second (rescue) dose of naloxone. A second dose of naloxone may be required where the participant has not satisfactorily recovered 15 minutes after initial presentation of overdose, ie: if the participant's Glasgow Coma Score is less than 13 and/or their respiratory rate is less than 10/minute.[15 minutes after first presentation of overdose]
- Secondary Outcome Measures
Name Time Method Glasgow Coma Score (GCS) greater than or equal to 13 as observed by trained clinician[From first administration of naloxone until 10 minutes post administration];Respiration rate greater than or equal to 10 per minute as observed by trained clinician[From first administration of naloxone until 10 minutes post administration]