Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/07/2009
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 Philip Whitehurst

ORCID ID

Contact details

Consultant Anaesthetist
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0557102800

Study information

Scientific title

Acronym

PaPoV

Study hypothesis

To assess the incidence of postoperative vomiting in children undergoing genital plastic surgery in a prospective, randomised, double blind study comparing ondansetron with cyclizine and placebo (normal saline).

Ethics approval

Not provided at time of registration

Study design

Randomised double blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Vomiting

Intervention

Prospective, controlled randomised double-blind trial.

Intervention type

Drug

Phase

Not Specified

Drug names

ondansetron cyclizine

Primary outcome measures

Number of vomits in the first 24 h from the time of extubation; doses of anti-emetics given because of vomiting in the first 24 h; time to first oral intake; complications (obtained retrospectively from case notes).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1997

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Children undergoing elective plastic genito-urinary procedures between the ages of 3 and 5, American Society of Anesthesiologists (ASA) grade I & II. 55 Children in each group.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

110

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/1997

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Anaesthetist
Dudley
DY1 2HQ
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

Hospital/treatment centre

Funder name

The Dudley Group of Hospitals 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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12886917

Publication citations

  1. Results

    O'Brien CM, Titley G, Whitehurst P, A comparison of cyclizine, ondansetron and placebo as prophylaxis against postoperative nausea and vomiting in children., Anaesthesia, 2003, 58, 7, 707-711.

Additional files

Editorial Notes