Effect of local sucralfate and clindamycin on reduction of post tonsillectomy pain in 6-12 years children: a triple blinded randomized controlled trial

Objective: To assess the effect of local sucralfate and clindamycin on reduction of post tonsillectomy pain in 4-12 years children. Design: A triple blinded randomized controlled trial. Setting: The eligible patients who were undergone tonsillectomy with or without adenoidectomy will refer to ENT clinic of Besat hospital in 2013. Inclusion criteria: (a) patients who were undergone tonsillectomy with or without adenoidectomy; (b) age of 6-12 years of both genders. Exclusion criteria: (a) sensitivity to sucralfate and clindamycin or any of the macrolide antibiotics; (b) having chronic diseases such as congenital malformation, haemorrhagic disease, and Type I diabetes. Intervention 1: oral irrigation with 10 ml of normal saline including clindamycin with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a day for three days. Intervention 2: oral irrigation with 10 ml of normal saline including sucralfate with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a day for three days. Control: oral irrigation with 10 ml of normal saline including cellulose (as plaocebo) with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a day for three days. Primary outcome: measuring daily sore throat for five days using Faces Pain Scale Revised with 0-10 scores. Secondary outcome: assessing adverse events during the first 5 days after surgery including: (a) nausea; (b) vomiting; (c) bleeding; (d) number of times of using acetaminophen; (e) number of times awaking at night; (f) bad breath; and (g) Otalgia

Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences