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 |
| Protocol serial number | N0263111537 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, double blind with a balanced design |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Level of pain, anxiety and discomfort. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| 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
- United Kingdom
- England
Study participating centre
Department of Paediatric Dentistry
London
WC1X 8LD
United Kingdom
WC1X 8LD
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 published | 22/09/2007 | Yes | No |
