Use of analgesic for children having dental treatment under local anaesthesia
| ISRCTN | ISRCTN98093105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98093105 |
| Protocol serial number | Version 5 |
| Sponsor | University College London Hospital (UK) |
| Funder | University College London |
- Submission date
- 08/02/2009
- Registration date
- 05/05/2009
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Alexandra Wing, first floor
UCL Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
| Phone | +44 (0)20 79151269 |
|---|---|
| p.ashley@eastman.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised placebo-controlled double-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Use of preoperative analgesic agents for children having dental treatment under local anaesthesia: a pilot randomised clinical controlled trial |
| Study objectives | Preoperative ibuprofen will reduce post-operative pain in children having dental treatment under local anaesthetic. |
| Ethics approval(s) | UCLH Research Ethics Committee A - submission pending |
| Health condition(s) or problem(s) studied | Postoperative pain after dental treatment in children |
| Intervention | Intervention group will be given ibuprofen syrup (oral): 4-7 years: 150 mg 7-10 years: 200 mg 10-12 years: 300 mg 12-18 years: 300-400 mg Control group: placebo |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ibuprofen |
| Primary outcome measure(s) |
The post-operative pain intensity score recorded using faces pain scale for the age group between 5-7 years, and the faces pain scale and Visual Analogue Scale (for accuracy) for the age group between 7-18 years. Measured 2, 4 and 6 hours after operation. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Children, both males and females, aged between 5 to 18 years 2. Children undergoing pulp treatment, preformed crowns, extraction, or surgical procedures under local anaesthesia |
| Key exclusion criteria | 1. Children who have medical condition that excludes them having ibuprofen such as bronchial asthma, allergy to non-steroidal anti-inflammatory drugs, bleeding disorders and renal and hepatic impairment 2. Any child with mental disability that prevent them from completing the pain scoring form 3. Any child who is allergic to paracetamol (as participants will be advised to take this post-operatively if additional painkillers are required postoperatively) 4. Any child who received any analgesic within 8 hours before the treatment 5. Any child who is involved in current research or has recently been involved in any research prior to recruitment |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/07/2020: No publications found.
04/08/2017: No publications found, verifying study status with principal investigator.
24/01/2013: The following changes were made to the record:
1. The overall trial start date was changed from 01/09/2009 to 01/09/2013.
2. The overall trial end date was changed from 01/12/2009 to 01/05/2015.
