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.

INTERVENTION: Trade Name: Lignospan Special Pharmaceutical Form: Injection* INN or Proposed INN: LIDOCAINE HYDROCHLORIDE CAS Number: 73789 Other descriptive name: Local Anaesthetic Concentration unit: % percent Concentration type: equal Concentration number: 2‐ CAS Number: 51423 Other descriptive name: ADRENALINE TARTRATE Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 1 in 80000‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Dental use CONDITION: Postoperative pain following oral surgery in 12 to 16 year olds ; MedDRA version: 9.1 Level: LLT Classification code 10024759 Term: Local anaesthetic ; MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain PRIMARY OUTCOME: 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? 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 Objective: 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