OPEN CONTROLLED TRIAL OF THE EFFICACY AND TOLERABILITY OF MORNIFLUMATE CHILD SUPPOSITORY VS ALPHA-AMYLASE SYRUP IN SORE THROAT

This open randomised two parallel arms multicenter trial compared the efficacy and tolerability of morniflumate child suppository 400 mg and of alpha-amylase syrup in the treatment of acute sore throat and phar yngitis. 168 children from both sexes, from 5 to 13 years old, present ing with a painful acute sore throat or pharyngitis present for less t han 48 hours, with a temperature greater than or equal to 38 degrees C have been included in the trial. These children have received during 4 days, in addition to an antibiotic treatment made of amoxicilline, e ither morniflumate suppository child at a dose of 40 mg/kg/day or alph a-amylase syrup at a dose of 3 teaspoons per day. Efficacy has been ev aluated from data gathered by the investigator during visits conducted after 2 days of treatment (D3) and 4 days of treatment (D5) and from daily evaluations by the parents. Morniflumate child suppository was s ignificantly more efficient than alpha-amylase in reducing spontaneous pharyngeal pains (p < 0.001) and deglutition induced pains (p < 0.001 ) than alpha-amylase after 48 hours of treatment (D3). This superiorit y persisted at D5 with regards to deglutition induced pain (p < 0.001) . The score of global efficacy at the end of the treatment was also be tter in the morniflumate child suppository group (p < 0.001). These re sults in favor of morniflumate child suppository have been confirmed b y childrens' self-evalution of the pain according to a face scale at D 3 and D5 and by different evaluations carried out each day by the pare nts (influence on appetite, sleep and usual activities). Frequency of observed adverse events were comparable in both groups (5 cases repres enting 6% with morniflumate child suppository, 4 cases representing 5% with alpha-amylase). Most of the cases consisted of digestive disorde rs (symptoms frequently found in children presenting with ENT diseases ). Thus, it is logical to consider a treatment by morniflumate child s uppository in case of sore throat (or pharyngitis) with major inflamma tory and/or painful elements.