Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
24/09/2013
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 S Bhatia

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes