Contact information
Type
Scientific
Primary contact
Dr Paul Ashley
ORCID ID
Contact details
Alexandra Wing
first floor
UCL Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
+44 (0)20 79151269
p.ashley@eastman.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 5
Study information
Scientific title
Use of preoperative analgesic agents for children having dental treatment under local anaesthesia: a pilot randomised clinical controlled trial
Acronym
Study hypothesis
Preoperative ibuprofen will reduce post-operative pain in children having dental treatment under local anaesthetic.
Please note that as of 24/01/2013, the following changes were made to the record:
1. The anticipated start date was updated from 01/09/2009 to 01/09/2013
2. The anticipated end date was updated from 01/12/2009 to 01/05/2015
Ethics approval
The study will be submitted to UCLH Research Ethics Committee A in March 2009.
Study design
Pilot randomised placebo-controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The post-operative pain intensity score will be 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. Post-operative pain will be measured 2, 4 and 6 hours after operation.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2013
Overall trial end date
01/05/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/09/2013
Recruitment end date
01/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Alexandra Wing, first floor
London
WC1X 8LD
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Eastman Dental Institute and Hospital, University College London (UK)
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