Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234131723
Study information
Scientific title
Acronym
Study hypothesis
Will the dilution of Fresenius 1% propofol using equal parts of 0.9% Sodium Chloride and 1% Fresenius propofol reduce the incidence of pain on injection in children aged 5 to 10 years?
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
Respiratory: Pain
Intervention
Children aged 5-10 years (up to approximately 30 kg) will be randomised to either a sample or control group. A single blinded observer will then watch for signs of discomfort on induction of anaesthesia during the injection of propofol. This will be defined as a motor response of the arm, a verbal complaint of pain, a cry and or grimace.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
A reduction in the incidence of pain on injection of Propofol when compared with the most commonly used and effective method in current practice (i.e. the addition of lignocaine - 2 ml 1% per 20 ml propofol).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
01/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children aged 5-10 years (up to approximately 30 kg) with American Society of Anesthesiologists (ASA) status 1 or 2 on elective surgical lists.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/11/2003
Recruitment end date
01/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
North Bristol NHS Trust (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
Basic results (scientific)
Publication list