Barium enema: does splitting the buscopan dose reduce patient discomfort, whilst maintaining image quality?
| ISRCTN | ISRCTN32878249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32878249 |
| Secondary identifying numbers | N0226127781 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 26/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Derrick F Martin
Scientific
Scientific
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 6237 |
|---|---|
| derrick.martin@smuht.nwest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Barium |
| Primary outcome measure | Completion of examination |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2003 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 200 patients attending for barium enema examination, 100 of which will be the controls |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
South Manchester University Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | abstract C52, P027 | 01/05/2005 | No | No |
