Randomised Controlled Trial of sedation for colonoscopy: Entonox versus Midazolam/Fentanyl

ISRCTN	ISRCTN81142957
DOI	https://doi.org/10.1186/ISRCTN81142957
Protocol serial number	N0084160165
Sponsor	Department of Health
Funder	The North and South Bank Research and Development Consortium (UK) - NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Graeme Duthie
Scientific

Acadmemic Surgical Unit
Hull and East Yorkshire Hospitals (NHS) Trust
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom

Phone	+44 (0)1482 623247
Email	G.S.Duthie@hull.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does nitrous oxide (Entonox) provide better pain relief than the conventional intravenous sedation during colonoscopy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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(s)	Pain score assessed by VAS
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	10/02/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	All patients undergoing elective colonoscopy would be prospective participants.
Key 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
Date of first enrolment	11/03/2005
Date of final enrolment	10/02/2006

Acadmemic Surgical Unit

Hull
HU16 5JQ
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?
Abstract results	conference proceedings	01/04/2009		No	No