Evaluation of a new formulation of Propofol-Lipuro regarding pain on injection in an elective paediatric population
| ISRCTN | ISRCTN53763593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53763593 |
| Protocol serial number | N0220173668 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Funders | Sheffield Children's Hospital NHS Trust (UK), NHS R&D Support Funding (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 18/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ayman Eissa
Scientific
Scientific
Sheffield Children's NHS Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 2717000 |
|---|---|
| ayman.eissa@sch.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Evaluation of a new formulation of Propofol-Lipuro regarding pain on injection in an elective paediatric population |
| Study objectives | Evaluation of a new formulation of Propofol-Lipuro regarding pain on injection in an elective paediatric population. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | The effects of the three formulations of this anaesthetic agent will be studied as the patient goes to sleep in the usual way for their operation. We will randomly allocate subjects into three groups prior to receiving the induction agent and injection pain will be evaluated by subjective and objective scoring of pain as they go to sleep. Intravenous canulation will be via a vein on the dorsum of the hand. After a small dose of the drug, they will be asked by the anaesthetist(s) about any soreness in their arm and to rate this as none, mild, moderate or severe. The anaesthetic and operation will proceed in the usual way after this. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Propofol-Lipuro |
| Primary outcome measure(s) |
The outcome measure is reduction of injection pain on induction of anaesthesia with a very commonly-used agent. Although Lipuro has been subject to clinical trials during its development, it has not been compared to other formulations in this way previously. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 29/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 13/02/2006 |
| Date of final enrolment | 29/11/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sheffield Children's NHS Trust
Sheffield
S10 2TH
United Kingdom
S10 2TH
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 |
Editorial Notes
18/05/2017: No publications found in PubMed, verifying study status with principal investigator.
