Condition category
Ear, Nose and Throat
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Laws

ORCID ID

Contact details

Department of Anaesthesia
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)191 5656256 ext 42446
david.laws@chs.northy.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0065091703

Study information

Scientific title

Acronym

Study hypothesis

To see whether giving a bolus of 20 ml intravenous dextrose 4%/saline 0.18% fluid reduces postoperative nausea and vomiting in children undergoing tonsillectomy.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Ear, Nose and Throat: Tonsillectomy

Intervention

Randomised controlled trial, patient, parent and ward nurses blinded to limb allocation, half the study group will receive a measured amount of intravenous fluid during the operation and half will not receive this intravenous fluid.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The incidence and severity of vomiting, pain and activity disturbance will be monitored and recorded for 3 days post surgery.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

01/07/2003

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Children aged between 2 and 15 years, both male and female undergoing tonsillectomy will be recruited.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2001

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

City Hospitals Sunderland 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