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 |
| Protocol serial number | N0185139342 |
| Sponsor | Department of Health |
| Funder | Plymouth Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Anaesthetic Department
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
