Comparison of caudal epidural using 0.25% bupivacaine and 0.5 mg/kg ketamine with penile block using 0.5% bupivacaine for postoperative analgesia following day case circumcision.
| ISRCTN | ISRCTN69774569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69774569 |
| Secondary identifying numbers | N0185139342 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A S Carr
Scientific
Scientific
Anaesthetic Department
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Analgesia |
| Intervention | Double blinded randomised controlled trial |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2002 |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Male |
| Target number of participants | 44 |
| Key inclusion criteria | 44 subjects all aged less than 16 years having elective day-case circumcisions. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetic Department
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Plymouth Hospitals 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
