Use of analgesic for children having dental treatment under local anaesthesia

ISRCTN	ISRCTN98093105
DOI	https://doi.org/10.1186/ISRCTN98093105
Secondary identifying numbers	Version 5

Submission date: 08/02/2009
Registration date: 05/05/2009
Last edited: 24/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Ashley
Scientific

Alexandra Wing, first floor
UCL Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom

Phone	+44 (0)20 79151269
Email	p.ashley@eastman.ucl.ac.uk

Study information

Study design	Pilot randomised placebo-controlled double-blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Use of preoperative analgesic agents for children having dental treatment under local anaesthesia: a pilot randomised clinical controlled trial
Study objectives	Preoperative ibuprofen will reduce post-operative pain in children having dental treatment under local anaesthetic.
Ethics approval(s)	UCLH Research Ethics Committee A - submission pending
Health condition(s) or problem(s) studied	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	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ibuprofen
Primary outcome measure	The post-operative pain intensity score 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. Measured 2, 4 and 6 hours after operation.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/09/2013
Completion date	01/05/2015

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/09/2013
Date of final enrolment	01/05/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UCL Eastman Dental Institute

London
WC1X 8LD
United Kingdom

Sponsor information

University College London Hospital (UK)
Hospital/treatment centre

235 Euston Road
London
NW1 2BU
England
United Kingdom

Phone	+44 (0)845 155 5000
Email	abc@email.com
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Hospital/treatment centre

University College London
Government organisation / Universities (academic only)

Alternative name(s): University College London in United Kingdom, Collegium Universitatis Londinensis, UCL
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/07/2020: No publications found.
04/08/2017: No publications found, verifying study status with principal investigator.
24/01/2013: The following changes were made to the record:
1. The overall trial start date was changed from 01/09/2009 to 01/09/2013.
2. The overall trial end date was changed from 01/12/2009 to 01/05/2015.