Contact information
Type
Scientific
Primary contact
Mr Michael Murphy
ORCID ID
Contact details
Department of Oral and Maxillofacial Surgery
Royal Gwent Hospital
Newport
NP20 2UB
United Kingdom
-
mike.murphy@gwent.wales.nhs.uk
Additional identifiers
EudraCT number
2008-000254-13
ClinicalTrials.gov number
Protocol/serial number
RD/613/07
Study information
Scientific title
A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on post-operative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment
Acronym
Study hypothesis
Intra-operative administration of local anaesthetic significantly reduces post-operative pain experience in children aged 12 to 16 years having ambulatory oral surgery to facilitate orthodontic treatment under general anaesthetic.
Ethics approval
South East Wales REC Panel B, 14/10/2008, ref: 08/WSE02/57
Study design
Double-blind randomised placebo-controlled study
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
Pain following ambulatory oral surgery
Intervention
Treatment group: standard dental local anaesthetic in the form 2% lidocaine hydrochloride with 1 in 80000 adrenaline by local injection
Control group: saline by local injection
Treatment takes place on a single day. No follow-up.
Intervention type
Drug
Phase
Not Applicable
Drug names
Lidocaine hydrochloride
Primary outcome measures
Post-surgical pain using a Visual Analogue Scale, measured pre-surgery, at 30 minutes, 1 hour and 2 hours post-surgery.
Secondary outcome measures
Measurement of time to rescue analgesia.
Overall trial start date
20/02/2009
Overall trial end date
20/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 12 to 16 years, either sex
2. Requiring surgery necessitating the raising of a mucoperiosteal flap and bone removal in at least one but not more than two sites
3. Suitable for ambulatory surgery
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
68
Participant exclusion criteria
1. Age under 12 years
2. History of allergy to local anaesthetic of the amide type or to any components of the injectable formulation, paracetamol or non-steroidal anti-inflammatory drugs
Exclusion criteria due to the presence of adrenaline in the local anaesthetic formula:
3. Arterial hypertension
4. Coronary disease
5. Valvular heart disease
Standard anaesthetic-based exclusions for ambulatory surgery:
6. American Society of Anaesthesiologists (ASA) grade greater than 2
7. Body mass index greater than 35
8. Poorly controlled asthma
Recruitment start date
20/02/2009
Recruitment end date
20/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Gwent Hospital
Newport
NP20 2UB
United Kingdom
Sponsor information
Organisation
Gwent Healthcare NHS Trust (UK)
Sponsor details
Research and Development Department
The Friars
Newport
NP20 4EZ
United Kingdom
-
mike.murphy@gwent.wales.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gwent Healthcare NHS Trust (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