A RCT investigation: paracetamol and ibruprofen in paediatric patients for management of pain following dental extractions under general anaesthesia
| ISRCTN | ISRCTN12132224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12132224 |
| Secondary identifying numbers | N0453150124 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 08/02/2010
- 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 I C Mackie
Scientific
Scientific
Central Manchester & Manchester Children's Uni Hospitals NHS Trust
Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
| Phone | +44 (0)161 275 6702 |
|---|---|
| iain.mackie@manchester.ac.uk |
Study information
| Study design | Randomised double blind controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Can post operative distress be reduced by administering a mixture of paracetamol and ibuprofen when compared with paracetamol or ibuprofen alone? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | Paracetamol and ibuprofen vs paracetamol or ibuprofen alone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | paracetamol and ibuprofen |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2004 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 188 with between 1 and 12 teeth extractions, 47 in each group |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Central Manchester & Manchester Children's Uni Hospitals NHS Trust
Manchester
M15 6FH
United Kingdom
M15 6FH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) NHS R&D Support Funding
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 | 01/05/2007 | Yes | No |
