A comparison of midazolam with fentanyl or pethidine as a sedation for colonoscopy.

ISRCTN	ISRCTN60349285
DOI	https://doi.org/10.1186/ISRCTN60349285
Protocol serial number	N0649155306
Sponsor	Department of Health
Funder	Queen Elizabeth Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Alistair McNair
Scientific

Consultant Gastroenetrologist
Queen Elizabeth Hospital NHS Trust
Stadium Road
Woolwich
London
SE18 4QH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	midazolam, fentanyl, pethidine
Primary outcome measure(s)	1. Patient pain experienced/recalled 2. Comparison between two sedation regimes
Key secondary outcome measure(s)	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?
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Consultant Gastroenetrologist

London
SE18 4QH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No