Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ayman Eissa

ORCID ID

Contact details

Sheffield Children's NHS Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2717000
ayman.eissa@sch.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0220173668

Study information

Scientific title

Acronym

Study hypothesis

Evaluation of a new formulation of Propofol-Lipuro regarding pain on injection in an elective paediatric population.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Propofol-Lipuro

Primary outcome measures

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 trial start date

13/02/2006

Overall trial end date

29/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

The sample size in each of the three groups is 30.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

13/02/2006

Recruitment end date

29/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Sheffield Children's Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes