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Trial registered on ANZCTR


Registration number
ACTRN12609000376246
Ethics application status
Approved
Date submitted
6/05/2009
Date registered
28/05/2009
Date last updated
12/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of adjuvant promethazine for the relief of the pain of renal colic.
Scientific title
Randomised controlled trial of adjuvant promethazine for the relief of the pain of renal colic.
Secondary ID [1] 281216 0
Promethazine in renal colic
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal colic 4727 0
Condition category
Condition code
Renal and Urogenital 237054 237054 0 0
Other renal and urogenital disorders
Renal and Urogenital 237214 237214 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised to adjuvant promethazine 25mg IV single dose or not, in addition to non-steroidal anti-inflammatory drug [NSAID] [indomethacin 100mg oral or per rectum [PR]] and morphine 2.5mg intravenous [IV], with additional 2.5mg increments at 10 minutely intervals as required.
Intervention code [1] 4498 0
Treatment: Drugs
Comparator / control treatment
NSAID [indomethacin 100mg oral or PR] and morphine 2.5mg IV with additioanl increments of 2.5mg at 10 minute intervals as required
Control group
Active

Outcomes
Primary outcome [1] 5895 0
Difference in median visual analogue pain score [VAS score] for the degree of pain experienced at enrolment, 10, 20, 30 and 60 minutes post treatment
Timepoint [1] 5895 0
enrolment, 10, 20, 30 and 60 minutes post treatment
Secondary outcome [1] 241938 0
Total dose of intravenous [IV] morphine required within 1st hour
Timepoint [1] 241938 0
Morphine requirement within the 1 hour period after initial druag administration
Secondary outcome [2] 241939 0
Proportion with >50% reduction in initial VAS for the degree of pain being experienced
Timepoint [2] 241939 0
10, 20, 30 and 60 minutes post treatment
Secondary outcome [3] 241940 0
Proportion with VAS pain score <30mm at each time point
Timepoint [3] 241940 0
10, 20, 30 and 60 minutes post treatment

Eligibility
Key inclusion criteria
Adults aged 18-60 with clinical diagnosis of renal colic, confirmed by computed tomography scan within 48 hours of presentation
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to anti-histamines, NSAIDS, morphine
Unable to consent
Hypotension bllod pressure [BP] <100
Active peptic ulcer disease

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)
Identification by clinician.
Sequential numbered randomsiation envelopes.
Drug drawn up by nurse not involved in clinical care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based randomisation tool
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/07/2009
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] 4908 0
Self funded/Unfunded
Name [1] 4908 0
Country [1] 4908 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Gordon St, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 4438 0
None
Name [1] 4438 0
Address [1] 4438 0
Country [1] 4438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6972 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 6972 0
Royal Melbourne Hospital, Royal Parade, Parkville VIC 3050
Ethics committee country [1] 6972 0
Australia
Date submitted for ethics approval [1] 6972 0
01/06/2009
Approval date [1] 6972 0
Ethics approval number [1] 6972 0

Summary
Brief summary
Kidney stones [renal colic] can be a very painful condition. Current recommendations suggest non-steroidal anti-inflammatory agents [e.g. ketorolac, indomethacin] as first line treatment, although it is recognised that many patients also need strong painkillers such as morphine. A recent report has suggested that anti-histamine drugs [such as promethazine] may also be effective. The aim of this study is to compare the combination of promethazine/ indomethacin/ morphine against indomethacin/ morphine on the amount of pain reported and total dose of morphine needed for patients with kidney stone pain.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 29576 0
Address 29576 0
Country 29576 0
Phone 29576 0
Fax 29576 0
Email 29576 0
Contact person for public queries
Name 12823 0
Anne-Maree Kelly
Address 12823 0
Joseph Epstein Centre for Emergency Medicine Research at Western Health, Sunshine Hospital, Furlong ROad, St Albans VIC 3021
Country 12823 0
Australia
Phone 12823 0
+ 61 [0]3 8345 1024
Fax 12823 0
Email 12823 0
[email protected]
Contact person for scientific queries
Name 3751 0
Anne-Maree Kelly
Address 3751 0
JECEMR, Sunshine Hospital, Furlong ROad, St Albans VIC 3021
Country 3751 0
Australia
Phone 3751 0
+ 61 [0]3 8345 1024
Fax 3751 0
Email 3751 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.