An investigation into the use of perioperative local analgesia in children undergoing dental treatment under day stay general anaesthesia
| ISRCTN | ISRCTN74717186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74717186 |
| Secondary identifying numbers | N0263111537 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/06/2008
- 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 P Ashley
Scientific
Scientific
Department of Paediatric Dentistry
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
| Phone | +44 020 7915 1000 |
|---|---|
| p.ashley@eastman.ucl.ac.uk |
Study information
| Study design | Prospective, double blind with a balanced design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Will the different preoperative local analgesia techniques affect the post-operative discomfort, pain and anxiety experienced in children below 6 years old undergoing dental treatment under general anaesthesia? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Anaesthesia/Sedation |
| Intervention | 1. Perioperative local analgesia delivered by infiltration 2. Perioperative local analgesia delivered by intraligamental injection 3. No perioperative local analgesia |
| Intervention type | Other |
| Primary outcome measure | Level of pain, anxiety and discomfort. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2002 |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 120 patients from Paediatric Dentistry |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Paediatric Dentistry
London
WC1X 8LD
United Kingdom
WC1X 8LD
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
Government
University College London 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 published | 22/09/2007 | Yes | No |
