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
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