Randomised Controlled Trial of sedation for colonoscopy: Entonox versus Midazolam/Fentanyl
| ISRCTN | ISRCTN81142957 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81142957 |
| Secondary identifying numbers | N0084160165 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 25/06/2010
- 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
Not provided at time of registration
Contact information
Mr Graeme Duthie
Scientific
Scientific
Acadmemic Surgical Unit
Hull and East Yorkshire Hospitals (NHS) Trust
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 623247 |
|---|---|
| G.S.Duthie@hull.ac.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 hypothesis | Does nitrous oxide (Entonox) provide better pain relief than the conventional intravenous sedation during colonoscopy |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Surgery: Sedation |
| Intervention | Prospective randomised controlled study. Pilot study initially involving 100 patients to determine statistical power. Pts will be randomised using the sealed envelope method of block randomisation. Patients randomised to the entonox group will be taught methods of use. Patients will be shown the visual analogue score for pain and asked to mark them. Those randomised to conventional intravenous sedation will be informed of same and will undergo colonoscopy using standard intravenous sedation protocols. Entonox group encouraged to inhale the nitrous oxide for a full 60 seconds initially and then as and when required throughout procedure. Post colonoscopy both groups will be asked to indicate pain using visual analogue scale in the recovery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain score assessed by VAS |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 11/03/2005 |
| Overall study end date | 10/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | All patients undergoing elective colonoscopy would be prospective participants. |
| Participant exclusion criteria | 1. History of chronic respiratory disease 2. History of colonic resection 3. Intolerance to the drugs 4. Patients with pre-existing adbominal or perianal pain 5. Unwilling participants |
| Recruitment start date | 11/03/2005 |
| Recruitment end date | 10/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Acadmemic Surgical Unit
Hull
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (UK) - NHS R&D Support Funding
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 | conference proceedings | 01/04/2009 | No | No |
