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 |
| Protocol serial number | N0453150124 |
| Sponsor | Department of Health |
| Funder | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind controlled clinical study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | paracetamol and ibuprofen |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 188 |
| 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
- United Kingdom
- England
Study participating centre
Central Manchester & Manchester Children's Uni Hospitals NHS Trust
Manchester
M15 6FH
United Kingdom
M15 6FH
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 | 01/05/2007 | Yes | No |
