A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on postoperative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment.
- Conditions
- Postoperative pain following oral surgery in 12 to 16 year oldsMedDRA version: 9.1Level: LLTClassification code 10024759Term: Local anaestheticMedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative pain
- Registration Number
- EUCTR2008-000254-13-GB
- Lead Sponsor
- Gwent Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age 12 to16years
Requiring surgery necessitating the raising of a mucoperiosteal flap and bone removal in at least one but not more than two sites
Suitable for ambulatory surgery
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Age under 12 years
History of allergy to local anaesthetic, paracetamol or non-steroidal anti-inflammatory drugs
ASA grade greater than 2
Body mass index greater than 35
Poorly controlled asthma
The last three criteria are standard anaesthetic-based exclusions for ambulatory surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does giving adolescent patients local anaesthetic while they are under general anaesthetic having oral surgery carried out reduce their post-operative pain experience?;Secondary Objective: ;Primary end point(s): Pain will be assessed up to two hours post surgery, that is just prior to discharge from the day surgery unit.
- Secondary Outcome Measures
Name Time Method