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
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
-
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.