The effect of emulsion formulation on Propofol injection pain

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Anthony McCluskey
Scientific

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

Primary study design	Interventional
Study design	Randomised double blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does Propofol Lipuro cause less injection pain than standard Propofol obviating the need to add Lidocaine local anaesthetic?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Injection pain experienced by patients during induction of general anaesthesia
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	Patients scheduled for surgery requiring general anaesthesia in whom Propofol is an appropriate anaesthetic induction agent
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2003
Date of final enrolment	30/04/2004

Birch House

Stockport
SK2 7JE
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?
Results article	results	01/12/2004		Yes	No