Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185139342
Study information
Scientific title
Acronym
Study hypothesis
The null hypothesis is that there is no difference in the quality and duration of post-operative analgesia after day-case circumcisions afforded by a caudal block using a mixture of bupivacaine and ketamine and a penile block using bupivacaine.
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
Other
Patient information sheet
Condition
Surgery: Analgesia
Intervention
Double blinded randomised controlled trial
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
44 subjects all aged less than 16 years having elective day-case circumcisions.
Participant type
Patient
Age group
Child
Gender
Male
Target number of participants
44
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic Department
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Plymouth 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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18652709
Publication citations
-
Results
Margetts L, Carr A, McFadyen G, Lambert A, A comparison of caudal bupivacaine and ketamine with penile block for paediatric circumcision., Eur J Anaesthesiol, 2008, 25, 12, 1009-1013, doi: 10.1017/S0265021508004833.