OBJECTIVE: The objective of this study is to evaluate the efficacy of sucralfate in alleviating posttonsilectomy morbidity in a pediatric group of patients. METHODS: A prospective, double-blind, randomized, and placebo-controlled study comparing the irrigation of a solution containing either 1g of sucralfate (study group) or 1g of lactulose (control group) was performed on 69 children aged 3-12 years, who underwent tonsillectomy at the University Hospital of Brasilia Medical School. The children were randomly assigned and each one used a solution containing sucralfate or lactulose to swish and swallow four times daily during 7 days. Eleven patients were excluded. The anesthetic was standardized and no premedication was used. Pain magnitude using an "Oucher" scale, nausea, vomiting, bleeding, earache, analgesic drug intake, changes in the interincisor teeth distance, and changes in the weight and temperature were assessed by the surgeon 6, 24h, and 7 days after the surgery. RESULTS: Patients in the study group had significantly lower pain scores in the initial 6 postoperative hours (p<0.05). The difference between the two groups was not statistically significant for the other periods following the procedure or on the evaluation of the other indices. CONCLUSIONS: The use of the sucralfate in pediatric patients undergoingtonsillectomy was not effective in reducing the postoperative morbidity according to the parameters used in this study. The surgical technique with careful mucosal dissection associated with postoperative caries could be more important in the reduction of posttonsilectomy morbidity.
RCT Entities:
OBJECTIVE: The objective of this study is to evaluate the efficacy of sucralfate in alleviating posttonsilectomy morbidity in a pediatric group of patients. METHODS: A prospective, double-blind, randomized, and placebo-controlled study comparing the irrigation of a solution containing either 1g of sucralfate (study group) or 1g of lactulose (control group) was performed on 69 children aged 3-12 years, who underwent tonsillectomy at the University Hospital of Brasilia Medical School. The children were randomly assigned and each one used a solution containing sucralfate or lactulose to swish and swallow four times daily during 7 days. Eleven patients were excluded. The anesthetic was standardized and no premedication was used. Pain magnitude using an "Oucher" scale, nausea, vomiting, bleeding, earache, analgesic drug intake, changes in the interincisor teeth distance, and changes in the weight and temperature were assessed by the surgeon 6, 24h, and 7 days after the surgery. RESULTS:Patients in the study group had significantly lower pain scores in the initial 6 postoperative hours (p<0.05). The difference between the two groups was not statistically significant for the other periods following the procedure or on the evaluation of the other indices. CONCLUSIONS: The use of the sucralfate in pediatric patients undergoing tonsillectomy was not effective in reducing the postoperative morbidity according to the parameters used in this study. The surgical technique with careful mucosal dissection associated with postoperative caries could be more important in the reduction of posttonsilectomy morbidity.