Trial Review

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
ACTRN12605000720617
Ethics application status
Approved
Date submitted
7/11/2005
Date registered
8/11/2005
Date last updated
8/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Nebulized fentanyl for pediatric extremity fracture
Scientific title
Nebulized Fentanyl for children with acute pain in the Emergency Department: A comparison with IV Morphine in children with suspected limb fractures for adequate pain relief in a less invasive manner
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric extremity fracture 870 0
Condition category
Condition code
Injuries and Accidents 937 937 0 0
Fractures
Other 938 938 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of neublized fentanyl to intravenous morphine (standard of care). Participants will be receiving nebulized fentanyl.

A "Faces" pain scale will be used for patients 5-13 years old with a clinical extremity fracture. Patients will received their randomized intervention for 30 minutes, with pain assessments at 0, 15 and 30 minutes. After 30 minutes, patient care will revert to current standard (intravenous morphine as needed).
Intervention code [1] 752 0
Treatment: Drugs
Comparator / control treatment
Participants will be receiving intravenous morphine (standard of care) and nebulized saline or just intravenous saline.

A "Faces" pain scale will be used for patients 5-13 years old with a clinical extremity fracture. Patients will received their randomized intervention for 30 minutes, with pain assessments at 0, 15 and 30 minutes. After 30 minutes, patient care will revert to current standard (intravenous morphine as needed).
Control group
Active

Outcomes
Primary outcome [1] 1232 0
Adequate analgesia
Timepoint [1] 1232 0
At 15 and 30 minutes
Secondary outcome [1] 2245 0
Timely analgesia.
Timepoint [1] 2245 0
Measuring pain at 0, 15, and 30 minutes, so our secondary outcome will be how long it takes for adequate analgesia to be achieved.

Eligibility
Key inclusion criteria
Pediatric patients aged 5-13 with clinical extremity fracture that would recieved intravenous morphine as standard of care. We will select patients with no co-morbidities.
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Numbered, premixed intravenous and nebulized treatment groups will be placed in a central pyxis machine. Sequential treatment pairs, previously randomly assigned, will be allocated in order of patient presentation. Blinding will be removed at the point of data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by coin toss
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2005
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] 1037 0
Hospital
Name [1] 1037 0
The Townsville Hospital Emergency Department
Country [1] 1037 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital Emergency Department
Address
Country
Australia
Secondary sponsor category [1] 899 0
None
Name [1] 899 0
none
Address [1] 899 0
Country [1] 899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2337 0
TTH ethics committe
Ethics committee address [1] 2337 0
Ethics committee country [1] 2337 0
Australia
Date submitted for ethics approval [1] 2337 0
Approval date [1] 2337 0
Ethics approval number [1] 2337 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35736 0
Address 35736 0
Country 35736 0
Phone 35736 0
Fax 35736 0
Email 35736 0
Contact person for public queries
Name 9941 0
Walter Grabowski
Address 9941 0
Emergency Department
The Townsville Hospital
100 Angus Road
Townsville QLD 4810
Country 9941 0
Australia
Phone 9941 0
+61 4 39798526
Fax 9941 0
Email 9941 0
[email protected]
Contact person for scientific queries
Name 869 0
Jeremy Furyk
Address 869 0
Emergency Department
The Townsville Hospital
100 Angus Road
Townsville QLD 4810
Country 869 0
Australia
Phone 869 0
+61 4 07057043
Fax 869 0
Email 869 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.