INTRANASAL CLONIDINE PREDICTION IN PEDIATRIC SURGERY: RANDOMIZED STUDY AGAINST PLACEBO

INTERVENTION: Trade Name: CATAPRESSAN solution injectable Clonidine Pharmaceutical Form: Concentrate and solvent for solution for injection Pharmaceutical form of the placebo: Concentrate for solution for injection Route of administration of the placebo: Perineural use CONDITION: intra‐nasal premedication instead of oral, intravenous or no premedication. ; MedDRA version: 20.0 Level: PT Classification code 10042609 Term: Surgery System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: Main Objective: The main objective of this study is to evaluate the efficacy of intranasal clonidine vs placebo in premedication in pediatric surgery on anxiolytic separation with parents. Primary end point(s): The primary endpoint is:; The anxiolytic score at 30 min after administration of premedication ie at; the time of separation with the parents.; The anxiolyse will be defined by a score greater than or equal to 3. Secondary Objective: The secondary objectives of this study are to evaluate the efficacy of; intranasal clonidine on anxiolysis at induction and on awakening, as well as the undesirable effects of premonication with clonidine. Timepoint(s) of evaluation of this end point: 30 min after administration of premedication ie at the time of; separation with the parents SECONDARY OUTCOME: Secondary end point(s): The secondary evaluation criteria are:; ‐ the acceptance of the mask at the induction of anesthesia,; The postoperative agitation measured by the anxiolytic score 15 min; after extubation and at the exit of SSPI,; ‐ the presence of adverse effects on the respiratory rate, defined by a value lower than the norm; ‐ the presence of a desaturation defined by an SpO2 value of less than or; equal to 94% for more than 30 seconds; ‐ the presence of undesirable effects on the heart rate, defined by a; value higher or lower than the norm; ‐ the tolerance of intranasal administration. Intolerance of; administration will be defined by crying of the child, a burning sensation; or a bitter taste to the administration of the product.; ‐ the existence of postoperative behavior disorders on D1 and D7,; defined by a score PHBQ> 68.; ‐ an increase in the time between the withdrawal of sevoflurane and; extubation; ‐ the need to administer morphine in the recovery room; ‐ the need for analgesics other than paracetamol in postoperative care Timepoint(s) of evaluation of this end point: At the induction of the anesthesia, 15 min after extubation and at the; exit of SSPI, J1 and at J7 post‐operative. INCLUSION CRITERIA: ‐ Age of 1 to 5 years, ‐ Weight from 10 to 25 kg ‐ Signature of informed consent ‐ ASA 1 or 2, (ANNEX 6) ‐ Scheduled minor surgery ‐ Affiliation to Social Security Are the trial subjects under 18? yes Number of subjects for this age range: 150 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