Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
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

Dr Alistair McNair

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0649155306

Study information

Scientific title

Acronym

Study hypothesis

Is there a significant difference between midazolam + fentanyl or midazolam + pethidine for colonoscopy sedation in terms of discomfort experienced by patients.

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

Not Specified

Patient information sheet

Condition

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 names

midazolam, fentanyl, pethidine

Primary outcome measures

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 trial start date

20/02/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients attending for colonoscopy (approx 2000 per year) will be eligible.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

2000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

20/02/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Gastroenetrologist
London
SE18 4QH
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

Queen Elizabeth Hospital NHS Trust (UK)

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 results in http://www.ncbi.nlm.nih.gov/pubmed/19251010

Publication citations

  1. Results

    Hayee B, Dunn J, Loganayagam A, Wong M, Saxena V, Rowbotham D, McNair A, Midazolam with meperidine or fentanyl for colonoscopy: results of a randomized trial., Gastrointest. Endosc., 2009, 69, 3 Pt 2, 681-687, doi: 10.1016/j.gie.2008.09.033.

Additional files

Editorial Notes