Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000058370
Ethics application status
Approved
Date submitted
28/01/2008
Date registered
30/01/2008
Date last updated
27/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double blinded, placebo controlled trial of the effect of self administered methoxyflurane using the Penthrox® Inhaler on tolerance of the Computed Tomography (CT) Enteroclysis procedure
Scientific title
For patients undergoing Computed Tomography (CT) Enteroclysis, self administered methoxyflurane via the Penthrox® inhaler may be better than placebo at improving patient tolerance of the procedure
Universal Trial Number (UTN)
Trial acronym
Penthrox for CTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CT enteroclysis tolerance 2775 0
Condition category
Condition code
Oral and Gastrointestinal 2907 2907 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methoxyflurane (Penthrox) is self administered by inhalation via the Penthrox Inhaler immediately before commencing the procedure. Patients can consume up to 1 vial (3 mL) of Penthrox.
Intervention code [1] 2514 0
Treatment: Drugs
Intervention code [2] 2517 0
Treatment: Drugs
Comparator / control treatment
Placebo is used in the form of Normal Saline. This is self administered by inhalation via the Penthrox inhaler immediately before commencing the procedure.
Control group
Placebo

Outcomes
Primary outcome [1] 3787 0
Overall patient comfort or discomfort during Computed Tomography Enteroclysis (CTE) as measured on a 10cm visual analogue scale
Timepoint [1] 3787 0
1 hour post procedure
Secondary outcome [1] 6391 0
Patient comfort or discomfort during specific stages of the Computed Tomgraphy (CTE) procedure (nasoduodenal intubation, enteric contrast infusion, CT scan)
Timepoint [1] 6391 0
1 hour post procedure

Eligibility
Key inclusion criteria
Referred for CT enteroclysis
Age 16 years or older
Able to give written informed consent themselves
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known pre-existing renal or hepatic impairment: serum creatinine = 1.5 x upper limit of normal range (ULNR) or bilirubin = 2 x upper limit of normal range (ULNR).
Concomitant use of any of the following medications: tetracyclines, gentamicin, kanamycin, colistin, polymyxin b, cephaloridine or amphotericin b.
Personal or familial hypersensitivity to fluorinated anaesthetics.
Personal or familial malignant hyperthermia.
Pre-medication with anxiolytic eg. midazolam, diazepam.
Pre-medication with breakthrough dose of analgesic eg. paracetamol plus codeine or oxycodone.
Hypotension pre-procedure: systolic blood pressure <90 mmHg.
Bradycardia pre-procedure: heart rate <50 bpm.
Poor oxygen saturation pre-procedure: O2 saturation <90%.
Pregnancy: currently pregnant or attempting to become pregnant.
Lactation: currently breastfeeding.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3029 0
Commercial sector/Industry
Name [1] 3029 0
Medical Developments International Limited
Country [1] 3029 0
Australia
Primary sponsor type
Individual
Name
Dr Alan Moss, Principal Investigator, Penthrox for CTE trial
Address
Department of Gastroenterology
Box Hill Hospital
Nelson Rd
Box Hill, Victoria 3128
Country
Australia
Secondary sponsor category [1] 2735 0
None
Name [1] 2735 0
Address [1] 2735 0
Country [1] 2735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4991 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 4991 0
Ethics committee country [1] 4991 0
Date submitted for ethics approval [1] 4991 0
Approval date [1] 4991 0
Ethics approval number [1] 4991 0

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

Contacts
Principal investigator
Name 28338 0
Address 28338 0
Country 28338 0
Phone 28338 0
Fax 28338 0
Email 28338 0
Contact person for public queries
Name 11495 0
Dr Alan Moss
Address 11495 0
Department of Gastroenterology
Box Hill Hospital
Nelson Rd
Box Hill, Victoria 3128
Country 11495 0
Australia
Phone 11495 0
61 3 9895 3333
Fax 11495 0
Email 11495 0
alan.moss@med.monash.edu.au
Contact person for scientific queries
Name 2423 0
Dr Alan Moss
Address 2423 0
Department of Gastroenterology
Box Hill Hospital
Nelson Rd
Box Hill, Victoria 3128
Country 2423 0
Australia
Phone 2423 0
61 3 9895 3333
Fax 2423 0
Email 2423 0
alan.moss@med.monash.edu.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.