Do bupivacaine and ketamine give superior analgesis compared to bupivacaine alone when used in a caudal epidural in children undergoing umbilical hernia repair?
| ISRCTN | ISRCTN74484781 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74484781 |
| Secondary identifying numbers | N0024108453 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lionel Davis
Scientific
Scientific
ITU
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8452 5137 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pain management |
| Intervention | Randomised controlled trial: A. Bupivacaine + Ketamine B. Bupivacaine (standard treatment) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/09/2001 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ITU
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Homerton University Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
