Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/08/2012
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 Lionel Davis

ORCID ID

Contact details

ITU
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8452 5137

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024108453

Study information

Scientific title

Acronym

Study hypothesis

Do bupivacaine and ketamine give superior analgesis compared to bupivacaine alone when used in a caudal epidural in children undergoing umbilical hernia repair?

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

Treatment

Patient information sheet

Condition

Pain management

Intervention

Randomised controlled trial:
A. Bupivacaine + Ketamine
B. Bupivacaine (standard treatment)

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Pain evaluation (Visual Analogue Scale [VAS] 'Oucher' Hanhallah Objective Pain Score) depending on age of the child.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

30 Study, 30 controls. American Society of Anesthesiologists (ASA) I & II children undergoing umbilical hernia repair as day cases at the Homerton and Royal London Hospitals.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/2001

Recruitment end date

30/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ITU
London
E9 6SR
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

Homerton University Hospital 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