A comparison of midazolam with fentanyl or pethidine as a sedation for colonoscopy.
| ISRCTN | ISRCTN60349285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60349285 |
| Secondary identifying numbers | N0649155306 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- 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
Dr Alistair McNair
Scientific
Scientific
Consultant Gastroenetrologist
Queen Elizabeth Hospital NHS Trust
Stadium Road
Woolwich
London
SE18 4QH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Is there a significant difference between midazolam + fentanyl or midazolam + pethidine for colonoscopy sedation in terms of discomfort experienced by patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Colonoscopy |
| Intervention | Patients must receive sedation for colonoscopy. They will be randomised to receive one of the two drug combinations, both of which are already used in this Trust. There will be no cost, safety or training implications, as the study will use existing practice and protocols. Data will be collected to compare efficacy, safety and acceptability of the two combinations. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | midazolam, fentanyl, pethidine |
| Primary outcome measure | 1. Patient pain experienced/recalled 2. Comparison between two sedation regimes |
| Secondary outcome measures | 1. Experience of pain related to Endoscopist 2. Patient expectation pre-endoscopy 3. Friendliness of staff 4. Incidence of adverse events during endoscopy 5. Need for more sedative 6. Desaturation 7. Agitation 8. Time taken for endoscopy (completion rate) 9. Time taken for recovery 10. Does patient's perception differ from Endoscopist, Nurse? |
| Overall study start date | 20/02/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 2000 |
| Key inclusion criteria | All patients attending for colonoscopy (approx 2000 per year) will be eligible. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 20/02/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Gastroenetrologist
London
SE18 4QH
United Kingdom
SE18 4QH
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
Queen Elizabeth Hospital 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? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2009 | Yes | No |
