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
Secondary identifying numbers	N0220173668

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

Sheffield Children's NHS Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Phone	+44 (0)114 2717000
Email	ayman.eissa@sch.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Propofol-Lipuro
Primary outcome measure	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.
Secondary outcome measures	Not provided at time of registration
Overall study start date	13/02/2006
Completion date	29/11/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	The sample size in each of the three groups is 30.
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

England
United Kingdom

Study participating centre

Sheffield Children's NHS Trust

Sheffield
S10 2TH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Sheffield Children's Hospital NHS Trust (UK)

No information available

NHS R&D Support Funding (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

Editorial Notes

18/05/2017: No publications found in PubMed, verifying study status with principal investigator.