A randomised controlled trial investigating the efficacy and safety of topical anaesthetic (0.25% Bupivacaine [Marcain]) in paediatric patients for the management of distress following dental extractions under general anaesthesia
| ISRCTN | ISRCTN32315461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32315461 |
| Protocol serial number | N0453113836 |
| Sponsor | Department of Health (UK) |
| Funder | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr IC Mackie
Scientific
Scientific
Central Manchester Healthcare NHS Trust
Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
| Phone | +44 (0)161 275 6702 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Bupivacaine vs standard practice |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate the effectiveness of topical anaesthetic (0.25% Bupivacaine) for reducing postoperative distress caused by pain in paediatric patients undergoing dental extractions under general anaesthesia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Anaesthesia/Sedation |
| Intervention | Prospective randomised clinical trial comparing use of topical anaesthetic against no postoperative anaesthetic. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure(s) |
Reduction of distress in children who have had teeth extracted under general anaesthesia. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 135 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/10/2002 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Central Manchester Healthcare NHS Trust
Manchester
M15 6FH
United Kingdom
M15 6FH
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 | 01/11/2004 | Yes | No |
