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 |
| Protocol serial number | N0024108453 |
| Sponsor | Department of Health (UK) |
| Funder | Homerton University Hospital NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Pain evaluation (Visual Analogue Scale [VAS] 'Oucher' Hanhallah Objective Pain Score) depending on age of the child. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
ITU
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
