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Trial registered on ANZCTR


Registration number
ACTRN12616001388404p
Ethics application status
Submitted, not yet approved
Date submitted
8/09/2016
Date registered
6/10/2016
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled pilot trial to assess the efficacy of Intravesical Pethidine in treating bladder spasm in children who have undergone Ureteric Reimplantation Surgery
Scientific title
A randomised controlled pilot trial to assess the efficacy of Intravesical Pethidine in treating bladder spasm in children who have undergone Ureteric Reimplantation Surgery
Secondary ID [1] 290118 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vesicoureteric Reflux 300217 0
Primary obstructive megaureter 300218 0
Ureteric Reimplantation 300219 0
Bladder Spasm 300220 0
Bladder ureterocele 300221 0
Condition category
Condition code
Surgery 300098 300098 0 0
Other surgery
Renal and Urogenital 300285 300285 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pethidine - intravesical, 1 mg/kg, as required up to every 4 hours post-operatively for bladder spasm until spasm resolved. Interventional drug to be administered by nursing staff and as such adherence will be monitored. Decision on whether drug to be given also made by nursing staff and/or clinician if available.
Intervention code [1] 295868 0
Treatment: Drugs
Comparator / control treatment
Control: intravesical normal saline, to volume equivalent of pethidine, PRN post-operatively for bladder spasm until spasm resolved
Control group
Placebo

Outcomes
Primary outcome [1] 299576 0
Pain Score. All patients will be assessed for pain (bladder spasm and wound scores) using standardised pain scores and pain assessment tools depending on their age and intellectual abilities by the ward nurses as well as by the research team. eg. Visual Analogue Scale, FPS-R (Faces Pain Scale - Revised),
Timepoint [1] 299576 0
Patients will be assessed for pain scores 2 hourly during the day and 4 hourly at night throughout the duration of their hospital admission. If the study drug (or placebo) is given they will be assessed: immediately prior to the instillation of the drug, during the installation of the drug, 5, 10, 15, 20, 30 and 60 min after the instillation.
Secondary outcome [1] 327584 0
Number of episodes of breakthrough pain from bladder spasm. To be documented by nursing staff at time of episode.
Timepoint [1] 327584 0
During hospital admission post-operatively
Secondary outcome [2] 327585 0
Overall analgesia requirements. Opioid consumption (via the fentanyl infusion) as well as the use and doses of rescue analgesia will be recorded at each assessment.
Timepoint [2] 327585 0
Throughout hospital admission post-operatively
Secondary outcome [3] 328060 0
Intensity of bladder spasms. To be documented using standardised pain scores and pain assessment tools depending on their age and intellectual abilities by the ward nurses as well as by the research team. eg. Visual Analogue Scale, FPS-R (Faces Pain Scale - Revised),
Timepoint [3] 328060 0
During post operative admission in hospital To be measured immediately prior to the instillation of the drug, during the installation of the drug, 5, 10, 15, 20, 30 and 60 min after the instillation.

Eligibility
Key inclusion criteria
Children undergoing ureteric reimplantation surgery under general anaesthetic at Princess Margaret Hospital, Perth, Western Australia. Children will be enrolled pre-operatively and eligibility will not be dependent on whether they experience bladder spasm.
Minimum age
6 Months
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children whose parents refuse informed consent.

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)
Double blinded. Study drug prepared by pharmacy. Patient, nursing staff, doctors and study coordinators blinded. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed with SPSS using descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6637 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 14258 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 294494 0
Charities/Societies/Foundations
Name [1] 294494 0
WA - Urological Society of Australia and New Zealand
Country [1] 294494 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Child and Adolescent Health Service
Level 1, CCRF, Roberts Rd, SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 293357 0
None
Name [1] 293357 0
Address [1] 293357 0
Country [1] 293357 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295928 0
Child and adolescent health service human research ethics committee
Ethics committee address [1] 295928 0
Ethics committee country [1] 295928 0
Australia
Date submitted for ethics approval [1] 295928 0
05/09/2016
Approval date [1] 295928 0
Ethics approval number [1] 295928 0
2015184

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

Contacts
Principal investigator
Name 68926 0
Mr Naeem Samnakay
Address 68926 0
Princess Margaret Hospital
Roberts Rd Subiaco WA 6008
Country 68926 0
Australia
Phone 68926 0
+61893408222
Fax 68926 0
Email 68926 0
naeem_samnakay@hotmail.com
Contact person for public queries
Name 68927 0
Timothy Greer
Address 68927 0
Princess Margaret Hospital
Roberts Rd Subiaco WA 6008
Country 68927 0
Australia
Phone 68927 0
+61893408222
Fax 68927 0
Email 68927 0
timothy.greer@health.wa.gov.au
Contact person for scientific queries
Name 68928 0
Timothy Greer
Address 68928 0
Princess Margaret Hospital
Roberts Rd Subiaco WA 6008
Country 68928 0
Australia
Phone 68928 0
+61893408222
Fax 68928 0
Email 68928 0
timothy.greer@health.wa.gov.au

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.