The use of pre-operative analgesia and intra-operative intra-crestal anaesthesia on teeth being extracted or restored under general anaesthetic for post-operative pain control in paediatric dentistry.
| ISRCTN | ISRCTN72395027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72395027 |
| Protocol serial number | N0013160113 |
| Sponsor | Department of Health |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Joanna Johnson
Scientific
Scientific
Paediatric Dentistry
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7881 7881 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the effectiveness of pre-emptive analgesia in children aged 5-12 years undergoing a dental general anaesthetic (DGA) for dental extractions +/- restorations. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | This is a randomised controlled trial utilising the half mouth design whereby patients undergoing extractions +/- restorative care will receive intra-setpal/crestal local anaesthetic in one side of the mouth versus nothing in the control side - each child will act as their own control. Standard post operative analgesia will be administered. |
| Intervention type | Other |
| Primary outcome measure(s) |
The effectiveness of intra-crestal analgesia for pain control in children. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 12 Years |
| Sex | Not Specified |
| Key inclusion criteria | Children aged 5-12 years undergoing DGA requiring symmetrical extractions +/- restorations under day stay DGA. |
| Key exclusion criteria | 1. Children unsuitable for day case dental general anaesthesia 2. Children aged < 5 years old 3. Children aged > 12 years old 4. Children at risk of endocarditis 5. Children with learning disabilities |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Paediatric Dentistry
London
SE1 9RT
United Kingdom
SE1 9RT
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 |
