Contact information
Type
Scientific
Primary contact
Prof Derrick F Martin
ORCID ID
Contact details
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6237
derrick.martin@smuht.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226127781
Study information
Scientific title
Acronym
Study hypothesis
To investigate if splitting the 20 mg of Buscopan (hyoscine-butylbromide) into two doses of 10 mg each, with one dose being administered at the usual point in the examination, and the second dose being administered just before the final images are obtained, will decrease patient discomfort, with no loss of image quality.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Barium enema
Intervention
1. 20 mg of buscopan (hyoscine-butylbromide) at the usual point in examination
2. 20 mg of buscopan (hyoscine-butylbromide) split into two doses of 10 mg each, with one dose being administered at the usual point in the examination, and the second dose being administered just before the final images are obtained
Intervention type
Drug
Phase
Not Specified
Drug names
Barium
Primary outcome measure
Completion of examination
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2003
Overall trial end date
01/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
200 patients attending for barium enema examination, 100 of which will be the controls
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2003
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Manchester University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in abstract form only: One or two does of buscopan for barium enema examination? Owen A, Limdi S, Raza A, England R, Hogg P, H-U Laasch, Martin D, European Radiology Supplements, Vol 15, Suppl 3, May 2005: C52, P027