The effect of emulsion formulation on Propofol injection pain
| ISRCTN | ISRCTN35049639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35049639 |
| Secondary identifying numbers | N0244124360 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anthony McCluskey
Scientific
Scientific
Birch House
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Study information
| Study design | Randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | Injection pain experienced by patients during induction of general anaesthesia |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2003 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birch House
Stockport
SK2 7JE
United Kingdom
SK2 7JE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Stockport NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2004 | Yes | No |
