Condition category
Surgery
Date applied
11/12/2008
Date assigned
23/01/2009
Last edited
10/05/2016
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

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

http://www.wales.nhs.uk/sites3/home.cfm?orgid=79

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

Publication citations

Additional files

Editorial Notes

10/05/2016: No publications found, verifying study status with principal investigator