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 |
| Protocol serial number | N0436125555 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind comparative trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| 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(s) |
Injection pain/no pain comparison between groups |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Anaesthetics
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
