Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Graeme Duthie

ORCID ID

Contact details

Acadmemic Surgical Unit
Hull and East Yorkshire Hospitals (NHS) Trust
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom
+44 (0)1482 623247
G.S.Duthie@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084160165

Study information

Scientific title

Acronym

Study hypothesis

Does nitrous oxide (Entonox) provide better pain relief than the conventional intravenous sedation during colonoscopy

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Phase

Phase IV

Drug names

Primary outcome measures

Pain score assessed by VAS

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/03/2005

Overall trial end date

10/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients undergoing elective colonoscopy would be prospective participants.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

United Kingdom

Trial participating centre

Acadmemic Surgical Unit
Hull
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (UK) - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 conference proceedings in http://www.ncbi.nlm.nih.gov/pubmed/19283736

Publication citations

  1. Conference proceedings

    Maslekar S, Gardiner A, Hughes M, Culbert B, Duthie GS, Randomized clinical trial of Entonox versus midazolam-fentanyl sedation for colonoscopy., Br J Surg, 2009, 96, 4, 361-368, doi: 10.1002/bjs.6467.

Additional files

Editorial Notes