The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000172202
Ethics application status
Approved
Date submitted
10/11/2008
Date registered
15/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Equivalency of two concentrations of fentanyl administered by the intranasal route for acute analgesia in children in a paediatric emergency department
Scientific title
Equivalency of two concentrations of fentanyl administered by the intranasal route for acute analgesia in children in a paediatric emergency department
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute pain 3959 0
Condition category
Condition code
Injuries and Accidents 4154 4154 0 0
Fractures
Anaesthesiology 4571 4571 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fentanyl is an opiate analgeisa used for relief of strong pain. Total dosage for both groups is the same; ie 1.5 mics/kg, however the concentration for the intervention group will be 50micrograms/ml and for the control group will be 300micrograms/ml. The dose will be administered and then repeated according to effect after 10minutes. If requied may have 2-3 doses during study period. Study period is 30 minutes after which time child's care will be taken over by usual medical and nursing staff. Administration of fentnayl takes seconds. Observation time is 30 minutes. Drug is administered intranasally
Intervention code [1] 3677 0
Treatment: Drugs
Comparator / control treatment
Intranasal Fentanyl (INF) will be administered 2-3 times as required - in general most patients will need only one dose (from previous studies). The drug will be admisnitered as soon as possible after arrival in the Emergency Department (ED) - after baseline observations and consent has been obtained. Participant's pain will be reassessed after 10 minutes and additional drugs admisnitered if necessary. An active drug is being given to all patients - the control group being the highly concetrated fentnayl (300micrograms/ml) have treatment for the same time as the standrard concentration (50micrograms/m). Observations and pain scores will be recorded prior to first administration of intranasal fentanyl (INF) and at 10, 20 and 30 minutes post administration. The fentanyl will be adminstered intranasally.
Control group
Active

Outcomes
Primary outcome [1] 5051 0
This study aims to illustrate the comparative effectiveness of a standard concentration intranasal fentanyl (INF) to the gold standard of highly concentrated INF. If equivalency can be proven, then standard solution can be recommended for intranasal use. This will reduce the cost of using INF for analgesia as standard concentration fentanyl is cheaper and more available than the highly concentrated fentanyl.
Outcome measurement is pain scores at 10,20,30 minutes
Timepoint [1] 5051 0
At 10, 20 and 30 minutes post administration
Secondary outcome [1] 8497 0
Any significant side effects (such as nausea, sedation, swelling, vomiting, itch and other) will be documented on the data collection sheet by the attending nurse.
Timepoint [1] 8497 0
30 minutes post administration of first dose of intranasal fentanyl (INF)

Eligibility
Key inclusion criteria
Children aged 3 to 15 years presenting to the emergency department with clinically deformed closed long bone fractures would be included.
Minimum age
3 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Administration of an opiate analgesic (excluding codeine) within 4 hours of arrival in ED, Head injury resulting in impaired judgement, Known allergies to opiate analgesics, Significantly blocked or traumatised nose preventing nasal administration, Inability to perform pain scoring, Compound fracture

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)
Allocation via a sealed envelope in the study pack.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be stratified into block according to age and then randomised according to simple randomisation by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4138 0
Self funded/Unfunded
Name [1] 4138 0
Address [1] 4138 0
Country [1] 4138 0
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children (PMH)
Address
Roberts Road
Subiaco, Perth
Western Australia
Australia 6008
Country
Australia
Secondary sponsor category [1] 3724 0
None
Name [1] 3724 0
Address [1] 3724 0
Country [1] 3724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6208 0
PMH Human Ethics Committee
Ethics committee address [1] 6208 0
Roberts Road
Subiaco, Perth
Western Australia
Australia 6008
Ethics committee country [1] 6208 0
Australia
Date submitted for ethics approval [1] 6208 0
10/11/2008
Approval date [1] 6208 0
Ethics approval number [1] 6208 0

Summary
Brief summary
Fentanyl is a pain-relieving agent that is commonly used to provide short term analgesia for painful procedures. This study aims to compare the effectiveness of two concentrations of intranasal fentanyl (INF) in children aged between 3 and 15 years presenting to the Emergency Department with clinically fractured long bones (arms or legs). These patients will be given either a highly concentrated solution or a standard concentration. Their pain scores and other observations will be recorded before they are given INF and at 10, 20 and 30 minutes after.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29116 0
Address 29116 0
Country 29116 0
Phone 29116 0
Fax 29116 0
Email 29116 0
Contact person for public queries
Name 12273 0
Meredith Borland
Address 12273 0
PMH ED
GPO Box D184
Perth WA 6840
Country 12273 0
Australia
Phone 12273 0
+61 8 93408222
Fax 12273 0
Email 12273 0
meredith.borland@health.wa.gov.au
Contact person for scientific queries
Name 3201 0
Meredith Borland
Address 3201 0
Princess Margaret Hospital
Emergency Department
GPO Box D184
Perth WA 6840
Country 3201 0
Australia
Phone 3201 0
+61 8 93408222
Fax 3201 0
Email 3201 0
meredith.borland@health.wa.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary