third molar theeth included needing surgical extraction MedDRA version: 12.1 Level: LLT Classification code 10044039 Term: Tooth extraction NOS
Conditions
Interventions
Trade Name: Naropin
Product Name: NAROPIN
Product Code: BE177353
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Naropin
CAS Number: 132112357
Current Sponsor code: BE 177353
Other de
Sponsors
CHU AMBROISE PARE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subject undergoing 3rd molar extraction (4 teeth) under generalised anaesthesia •Age = 12 years •Subject has given voluntary written informed consent •Subject is in the investigator’s opinion, willing and able to comply with the protocol requirements •Subject has an ASA scoring of I or II •Subject has the following laboratory values at baseline: -platelet count = 50x109/L -PTT > 40 sec •Male or female subject who is post-menopausal, surgically sterilized or willing to use an acceptable method of birth control for the duration of the study •Subject is in the investigator’s opinion able to complete a visual analogue scale Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •History of parodontal pathology or local inflammation at site of teeth extraction •Subject had major surgery within 4 weeks before enrolment •Subject with myocardial infarction within 6 months prior enrolment or with NHYA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. •Subject has another serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair toleranceto therapy or prolong recovery. •Subject has an active systemic infection requiring treatment •Female subject is pregnant or breast feeding •Subject enrolled in another clinical trial and/or receiving an investigational agent that will contra-indicate the use of Ropivacaïne® or xylocaïne®. Subjects are allowed to simultaneously participate to non-investigational trials. •Known allergy to Ropivacaïne® or xylocaïne® or other local anesthetics agents of the amide type •Patients with ongoing history of epilepsy •Chronic treatment with opioïds •History of ongoing gastric ulcer •History of ongoing intracardiac conduction block •Administration of beta blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To determine the sedation and analgesic effect of ropivacaïne® compared to xylocaïne®.;Secondary Objective: To compare patient complains in both treatment arms. To compare anaesthetists complains during surgery in both treatment arms Safety evaluation in term of incidence and severity of adverse events ;Primary end point(s): To compare sedation and antalgic used during surgery for teeth extraction and in post operative period. To compare patient complains in both treatment arms. To compare anaesthetists complains during surgery in both treatment arms. | — |
Countries
Belgium
Outcome results
None listed