Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes