A randomised double-blind comparative trial investigating the level of pain experienced on induction of anaesthesia using either standard Propofol 1% or Propofol-Lipuro 1% with or without the addition of lignocaine 2% (1:10 ratio)
| ISRCTN | ISRCTN10285854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10285854 |
| Secondary identifying numbers | N0436125555 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 05/09/2012
- 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 A Mallick
Scientific
Scientific
Anaesthetics
D Floor, Jubilee Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 243 2799 |
|---|---|
| Abhiram.Mallick@leedsth.nhs.uk |
Study information
| Study design | Randomised double-blind comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To determine which propofol preparation affords the least pain on injection. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | 1. Standard Therapy 2. New Therapy |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Standard Propofol 1% or Propofol-Lipuro 1% with or without the addition of lignocaine 2% |
| Primary outcome measure | Injection pain/no pain comparison between groups |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients undergoing uncomplicated elective surgery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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
Government
Leeds Teaching Hospitals 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 | 01/05/2007 | Yes | No |
