Pain prevention during propofol infusion in pediatric: hypnoanalgesia of the hand versus lidocaine.

INTERVENTION: Trade Name: Propofol PANPHARMA Product Name: Propofol Pharmaceutical Form: Emulsion for injection Trade Name: CHLORHYDRATE DE LIDOCAINE Product Name: CHLORHYDRATE DE LIDOCAINE Pharmaceutical Form: Solution for injection CONDITION: surgery under general anaesthetic ; MedDRA version: 20.0 Level: PT Classification code 10054799 Term: Perioperative analgesia System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Evaluate the efficacity of hypnoanalgesia of the hand in order to reduce propofol‐induced pain in children compared to the administration of a lidocaine‐propofol admixture Primary end point(s): The primary end point is the pain intensity evaluated by the Cameron's score. Secondary Objective: The secondary objectives of the trial is to evaluate the satisfaction of patient's anaesthetic, post surgery. Timepoint(s) of evaluation of this end point: 15 minutes SECONDARY OUTCOME: Secondary end point(s): The secondary end point is the patient's satisfaction about anesthesia, evaluated by a modified Aldrete 3 score. Timepoint(s) of evaluation of this end point: 8 hours INCLUSION CRITERIA: ‐ aged 7 to 14, ‐ ASA I and II, ‐ Admitted for scheduled surgery under general anaesthetic Are the trial subjects under 18? yes Number of subjects for this age range: 100 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