Contact information
Type
Scientific
Primary contact
Dr I C Mackie
ORCID ID
Contact details
Central Manchester & Manchester Children's Uni Hospitals NHS Trust
Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 275 6702
iain.mackie@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453150124
Study information
Scientific title
Acronym
Study hypothesis
Can post operative distress be reduced by administering a mixture of paracetamol and ibuprofen when compared with paracetamol or ibuprofen alone?
Ethics approval
Not provided at time of registration
Study design
Randomised double blind controlled clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oral Health
Intervention
Paracetamol and ibuprofen vs paracetamol or ibuprofen alone
Intervention type
Drug
Phase
Not Applicable
Drug names
paracetamol and ibuprofen
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2004
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
188 with between 1 and 12 teeth extractions, 47 in each group
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/2004
Recruitment end date
01/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Central Manchester & Manchester Children's Uni Hospitals NHS Trust
Manchester
M15 6FH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17397460
Publication citations
-
Results
Gazal G, Mackie IC, A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial., Int J Paediatr Dent, 2007, 17, 3, 169-177, doi: 10.1111/j.1365-263X.2006.00806.x.