Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205128954
Study information
Scientific title
Acronym
Study hypothesis
Does the administration of IV fluids intra-operatively reduce the incidence of post-operative nausea and vomiting in children undergoing day-surgery?
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
Prevention
Patient information sheet
Condition
Nausea and vomiting; surgery
Intervention
Randomised double blind controlled trial
Group 1: Children will receive 20 ml/kg of IV compound sodium lactate solution intra-operatively
Group 2: Children will receive no intravenous fluid intra-operatively
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of nausea and vomiting
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2003
Overall trial end date
01/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
300 children between 2 and 12 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/2003
Recruitment end date
01/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic Dept
London
E1 1BB
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
Government
Funder name
Barts and The London 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
Results - basic reporting
Publication summary