Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000052639
Ethics application status
Approved
Date submitted
27/07/2005
Date registered
29/07/2005
Date last updated
29/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Headaches after lumbar puncture
Scientific title
The frequency and functional impact of post lumbar puncture headache in children with cancer: a randomised cross over trial of 22 gauge versus 25 gauge lumbar puncture needles.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post lumbar puncture headache in children receiving treatment for cancer requiring general anaesthesia. 123 0
Condition category
Condition code
Cancer 138 138 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double blind, randomised crossover trial. A single experienced doctor will perform all of the lumbar punctures (LP) under general anaesthesia. A standard LP needle (PORTLAND) will be used. Orientation of the bevel will be parallel to the long axis of the dural fibres. The doctor cannot be blinded to the needle type. All children will be given a sequence of 4 LP's during their treatment for cancer. Twice with each of the 22g and 25g LP needles. Following each procedure, parents will be given a 1 page questionnaire by the RA. The same RA will phone interview them on days 1, 3, and 7 with the same questions. On day 7 more detailed questions will be asked if the patient experiences any headache. These questions will look into issues such as, timing of headache, analgesia required and functional impact on the family.
Intervention code [1] 70 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 174 0
Presence or absence of headache with postural characteristics as reported by parents
Timepoint [1] 174 0
On days 1, 3 and 7.
Primary outcome [2] 175 0
Presence or absence of headache with postural characteristics when using 22g needle versus 25g needle
Timepoint [2] 175 0
Measured by log linear modelling or generalised estimating equation (GEE) at project conclusion by professional services.
Primary outcome [3] 176 0
Functional impact on family
Timepoint [3] 176 0
Data provided via phone interview at day 7.
Primary outcome [4] 177 0
Reduction in function impact if 25g needle is used
Timepoint [4] 177 0
Phone interview at day 7.
Primary outcome [5] 178 0
Time of procedure, needle insertion and removal from skin
Timepoint [5] 178 0
Timed with a stop watch by an anaesthesia technician in the operating theatre.
Secondary outcome [1] 381 0
Presence or absence of any headache
Timepoint [1] 381 0
Reported by parents at days 1, 3 and 7.
Secondary outcome [2] 382 0
Presence of headaches from use of 22g and 25g needles.
Timepoint [2] 382 0
Outcome to be measured by log linear modelling or GEE at project conclusion by professional services.
Secondary outcome [3] 383 0
Time required for collection of CSF.
Timepoint [3] 383 0
Timed by an anaesthesia technician with stop watch during the lumbar puncture.

Eligibility
Key inclusion criteria
Children having LP's as standard treatment for malignancies, requiring general anaesthesia, in the day surgery unit.
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Families requiring interpreters. Patients requiring bone marrow aspirate and trephines on the same day. Unavailability of designated experienced doctor. Patients requiring emergency LP's in other anaesthetising locations.Patients with existing lumbar puncture headaches.

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)
One large envelope with patient study number, containing four smaller sealed opaque envelopes with study number and procedure A,B,C,D. Research Assistant (RA) provides envelope to proceduralist in order. Needle size concealed from both patient and RA. Staff in theatre are specifically instructed not to discuss needle size allocation with RA or patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation (using randomly permuted block sizes). This provides optimal design for most purposes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 191 0
Self funded/Unfunded
Name [1] 191 0
Fundraising by researchers
Country [1] 191 0
Primary sponsor type
Name
None
Address
Country
Secondary sponsor category [1] 142 0
None
Name [1] 142 0
None
Address [1] 142 0
Country [1] 142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 953 0
Royal Children's Hospital Ethics Committee
Ethics committee address [1] 953 0
Ethics committee country [1] 953 0
Australia
Date submitted for ethics approval [1] 953 0
Approval date [1] 953 0
Ethics approval number [1] 953 0

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

Contacts
Principal investigator
Name 35802 0
Address 35802 0
Country 35802 0
Phone 35802 0
Fax 35802 0
Email 35802 0
Contact person for public queries
Name 9259 0
Jenny Fuller
Address 9259 0
Department of Anaesthesia
Royal Children's Hospital
Flemington Road
Parkville Melbourne VIC 3052
Country 9259 0
Australia
Phone 9259 0
+61 3 93455233
Fax 9259 0
+61 3 93456003
Email 9259 0
[email protected]
Contact person for scientific queries
Name 187 0
Dr Catherine Crock
Address 187 0
Adolescent Health/Laboratory Service
Royal Children's Hospital
Flemington Road
Parkville Melbourne VIC 3052
Country 187 0
Australia
Phone 187 0
+61 3 93455522
Fax 187 0
+61 3 93491819
Email 187 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.