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Trial registered on ANZCTR


Registration number
ACTRN12606000322538
Ethics application status
Approved
Date submitted
18/07/2006
Date registered
26/07/2006
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of intranasal administration of Naloxone by paramedics for the successful treatment of suspected heroin overdose in the prehospital setting.
Scientific title
The efficacy of intranasal administration of Naloxone by paramedics for the successful treatment of suspected heroin overdose in the prehospital setting.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opiate Overdose 1292 0
Condition category
Condition code
Mental Health 1382 1382 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1213 0
Treatment: Devices
Comparator / control treatment
Intranasal (IN) Naloxone is the intervention and Intramuscular (IM) Naloxone is the control. Patients in the control group received 2mg IM naloxone. Participants received only 1 dose of IM naloxone. After 10 minutes, patients without adequate response were administered secondary naloxone treatment [endpoint] via the IM route [2mg].
Control group
Active

Outcomes
Primary outcome [1] 1886 0
Requirement for subsequent treatment with Naloxone
Timepoint [1] 1886 0
At 10 minutes from randomisation treatment.
Secondary outcome [1] 3326 0
Time to adequate and effective spontaneous respirations.
Timepoint [1] 3326 0
10 minutes.
Secondary outcome [2] 3327 0
Time to adequate consciousness.
Timepoint [2] 3327 0
10 minutes

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Client rousable i.e. GCS Greater than 12.Major facial trauma/blocked nasal passages/epistaxis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Conclealed envelope with randomisation advice enclosed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1516 0
Government body
Name [1] 1516 0
Department of Human Services, Australian Government.
Country [1] 1516 0
Australia
Primary sponsor type
Government body
Name
Department of Human Services, Australian Government.
Address
18/120 Spencer St
Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 1331 0
None
Name [1] 1331 0
Nil
Address [1] 1331 0
Country [1] 1331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2939 0
Melbourne Health Research Directorate
Ethics committee address [1] 2939 0
Ethics committee country [1] 2939 0
Australia
Date submitted for ethics approval [1] 2939 0
Approval date [1] 2939 0
20/02/2006
Ethics approval number [1] 2939 0
2001.172
Ethics committee name [2] 2940 0
Monash University
Ethics committee address [2] 2940 0
Ethics committee country [2] 2940 0
Australia
Date submitted for ethics approval [2] 2940 0
Approval date [2] 2940 0
05/12/2005
Ethics approval number [2] 2940 0
2005/813MC

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35382 0
Address 35382 0
Country 35382 0
Phone 35382 0
Fax 35382 0
Email 35382 0
Contact person for public queries
Name 10402 0
Debra Kerr
Address 10402 0
The Joseph Epstein Centre for Emergency Medicine Research
Sunshine Hospital
176 Furlong Rd
St Albans VIC 3021
Country 10402 0
Australia
Phone 10402 0
+61 3 83451027
Fax 10402 0
+61 3 83451019
Email 10402 0
[email protected]
Contact person for scientific queries
Name 1330 0
Debra Kerr
Address 1330 0
The Joseph Epstein Centre for Emergency Medicine Research
Sunshine Hospital
176 Furlong Rd
St Albans VIC 3021
Country 1330 0
Australia
Phone 1330 0
+61 3 83451027
Fax 1330 0
+61 3 83451019
Email 1330 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.