Javaneh Jahanshahi1, Sara Pazira1, Farhad Farahani1, Farnaz Hashemian1, Narges Shokri2, Behruz Karkhanei3, Jalal Poorolajal4. 1. Department of Ear-Nose-Throat Surgery, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran. 2. Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran. 3. Department of Anesthesiology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran. 4. Modeling of Noncommunicable Diseases Research Center, Department of Epidemiology and Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.
Abstract
IMPORTANCE: Postoperative sore throat is one of the most common problems after tonsillectomy. Antibiotics remove the local flora and reduce inflammation and thus may reduce postoperative pain after tonsillectomy. OBJECTIVE: To assess the effect of topical sucralfate and clindamycin on local pain reduction after tonsillectomy in children aged 6 to 12 years. DESIGN, SETTING, AND PARTICIPANTS: Triple-blind randomized clinical trial of children aged 6 to 12 years with sleep apnea or snoring due to adenotonsillar hypertrophy and chronic airway obstruction or with chronic infections who were candidates for tonsillectomy at Besat Hospital, Hamadan University of Medical Sciences, from May to October 2013. INTERVENTIONS: Patients were randomly assigned to receive sucralfate mouthwash, clindamycin mouthwash, or placebo (cellulose). The oral cavity was washed before and immediately after surgery with 10 mL of the prepared solution for 1 minute and then suctioned. Then, 8 hours after surgery, the patients were asked to keep 10 mL of the prepared mouthwash solution in their mouths for 1 minute 3 times a day for 3 days. MAIN OUTCOMES AND MEASURES: Postoperative sore throat evaluated daily for 5 days using the Faces Pain Scale-Revised. RESULTS: Of 110 patients enrolled, 101 patients remained for analysis. Patients in the placebo group had significantly higher mean (SD) throat pain scores than did patients in both drug groups on postsurgery days 1 through 4. Day 1 scores were 8.00 (1.84) for placebo and 6.00 (1.84) for sucralfate and 6.79 (1.87) for clindamycin (P = .001). Pain scores were not significantly different on day 5. Acetaminophen use was more common in the placebo group on days 3 and 4 (2.97 and 2.44) vs the sucralfate group (2.24 and 2.15) and the clindamycin group (2.36 and 2.12) (P = .001 and .02, respectively). Bleeding on day 1 was more common in the placebo group (3 of 34) vs none in the drug groups. Food intolerance on day 1 was less common in patients receiving sucralfate (2 of 34) than placebo (9 of 34) or clindamycin (11 of 33) (P = .02). There was no significant difference among the 3 groups in numbers of episodes of nocturnal waking, halitosis, earache, nausea, and vomiting. CONCLUSIONS AND RELEVANCE: This trial indicated that topical sucralfate and clindamycin are safe drugs with no important adverse effects that can significantly reduce posttonsillectomy pain in children and help them return to normal life sooner. TRIAL REGISTRATION: Iranian Registry of Clinical Trials registration number: IRCT201303209014N16.
RCT Entities:
IMPORTANCE: Postoperative sore throat is one of the most common problems after tonsillectomy. Antibiotics remove the local flora and reduce inflammation and thus may reduce postoperative pain after tonsillectomy. OBJECTIVE: To assess the effect of topical sucralfate and clindamycin on local pain reduction after tonsillectomy in children aged 6 to 12 years. DESIGN, SETTING, AND PARTICIPANTS: Triple-blind randomized clinical trial of children aged 6 to 12 years with sleep apnea or snoring due to adenotonsillar hypertrophy and chronic airway obstruction or with chronic infections who were candidates for tonsillectomy at Besat Hospital, Hamadan University of Medical Sciences, from May to October 2013. INTERVENTIONS:Patients were randomly assigned to receive sucralfate mouthwash, clindamycin mouthwash, or placebo (cellulose). The oral cavity was washed before and immediately after surgery with 10 mL of the prepared solution for 1 minute and then suctioned. Then, 8 hours after surgery, the patients were asked to keep 10 mL of the prepared mouthwash solution in their mouths for 1 minute 3 times a day for 3 days. MAIN OUTCOMES AND MEASURES: Postoperative sore throat evaluated daily for 5 days using the Faces Pain Scale-Revised. RESULTS: Of 110 patients enrolled, 101 patients remained for analysis. Patients in the placebo group had significantly higher mean (SD) throat pain scores than did patients in both drug groups on postsurgery days 1 through 4. Day 1 scores were 8.00 (1.84) for placebo and 6.00 (1.84) for sucralfate and 6.79 (1.87) for clindamycin (P = .001). Pain scores were not significantly different on day 5. Acetaminophen use was more common in the placebo group on days 3 and 4 (2.97 and 2.44) vs the sucralfate group (2.24 and 2.15) and the clindamycin group (2.36 and 2.12) (P = .001 and .02, respectively). Bleeding on day 1 was more common in the placebo group (3 of 34) vs none in the drug groups. Food intolerance on day 1 was less common in patients receiving sucralfate (2 of 34) than placebo (9 of 34) or clindamycin (11 of 33) (P = .02). There was no significant difference among the 3 groups in numbers of episodes of nocturnal waking, halitosis, earache, nausea, and vomiting. CONCLUSIONS AND RELEVANCE: This trial indicated that topical sucralfate and clindamycin are safe drugs with no important adverse effects that can significantly reduce posttonsillectomy pain in children and help them return to normal life sooner. TRIAL REGISTRATION: Iranian Registry of Clinical Trials registration number: IRCT201303209014N16.