Does the administration of intravenous (IV) fluids intra-operatively reduce the incidence of post-operative nausea and vomiting in children undergoing day-surgery?

ISRCTN ISRCTN89982548
DOI https://doi.org/10.1186/ISRCTN89982548
Secondary identifying numbers N0205128954
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
24/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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 S Bhatia
Scientific

Anaesthetic Dept
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectivesDoes the administration of IV fluids intra-operatively reduce the incidence of post-operative nausea and vomiting in children undergoing day-surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNausea and vomiting; surgery
InterventionRandomised 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 typeProcedure/Surgery
Primary outcome measureIncidence of nausea and vomiting
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2003
Completion date01/06/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit12 Years
SexBoth
Target number of participants300
Key inclusion criteria300 children between 2 and 12 years
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/09/2003
Date of final enrolment01/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthetic Dept
London
E1 1BB
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Barts and The London NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan