Condition category
Signs and Symptoms
Date applied
08/02/2009
Date assigned
05/05/2009
Last edited
24/01/2013
Prospective/Retrospective
Prospectively 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 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

Sponsor information

Organisation

University College London Hospital (UK)

Sponsor details

235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)845 155 5000

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes