Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/07/2009
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 Anthony McCluskey

ORCID ID

Contact details

Birch House
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0244124360

Study information

Scientific title

Acronym

Study hypothesis

Does Propofol Lipuro cause less injection pain than standard Propofol obviating the need to add Lidocaine local anaesthetic?

Ethics approval

Not provided at time of registration

Study design

Randomised double blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

Patients were allocated randomly into two groups to receive either Propofol-Lipuro without added lidocaine or Diprivan mixed with lidocaine 10 mg.
5 ml of the study solution was injected at a constant rate over 15 s and patients graded any associated pain or discomfort using a four-point verbal rating scale.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Injection pain experienced by patients during induction of general anaesthesia

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients scheduled for surgery requiring general anaesthesia in whom Propofol is an appropriate anaesthetic induction agent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2003

Recruitment end date

30/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birch House
Stockport
SK2 7JE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Stockport 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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15549974

Publication citations

  1. Results

    Kam E, Abdul-Latif MS, McCluskey A, Comparison of Propofol-Lipuro with propofol mixed with lidocaine 10 mg on propofol injection pain., Anaesthesia, 2004, 59, 12, 1167-1169, doi: 10.1111/j.1365-2044.2004.03964.x.

Additional files

Editorial Notes