Jahanshahi Javaneh, Pazira Sara, Farahani Farhad, Hashemian Farnaz, Shokri Narges, Karkhanei Behruz, Poorolajal Jalal
Department of Ear-Nose-Throat Surgery, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.
JAMA Otolaryngol Head Neck Surg. 2014 Aug;140(8):698-703. doi: 10.1001/jamaoto.2014.979.
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.
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.
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.
Postoperative sore throat evaluated daily for 5 days using the Faces Pain Scale-Revised.
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.
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.
Iranian Registry of Clinical Trials registration number: IRCT201303209014N16.
术后咽痛是扁桃体切除术后最常见的问题之一。抗生素可清除局部菌群并减轻炎症，因此可能减轻扁桃体切除术后的疼痛。
评估局部应用硫糖铝和克林霉素对6至12岁儿童扁桃体切除术后局部疼痛减轻的效果。
设计、地点和参与者：2013年5月至10月在哈马丹医科大学贝萨特医院进行的一项三盲随机临床试验，研究对象为6至12岁因腺样体扁桃体肥大和慢性气道阻塞导致睡眠呼吸暂停或打鼾，或患有慢性感染且适合进行扁桃体切除术的儿童。
患者被随机分配接受硫糖铝漱口水、克林霉素漱口水或安慰剂（纤维素）。术前和术后立即用10毫升配制好的溶液冲洗口腔1分钟，然后抽吸。然后，术后8小时，要求患者每天3次将10毫升配制好的漱口水溶液含在口中1分钟，持续3天。
使用面部疼痛量表修订版对术后咽痛进行为期5天的每日评估。
110名入组患者中，101名患者留作分析。在术后第1至4天，安慰剂组患者的平均（标准差）咽痛评分显著高于两个药物组。第1天，安慰剂组评分为8.00（1.84），硫糖铝组为6.00（1.84），克林霉素组为6.79（1.87）（P = 0.001）。第5天疼痛评分无显著差异。在第3天和第4天，安慰剂组使用对乙酰氨基酚的情况比硫糖铝组（2.24和2.15）和克林霉素组（2.36和2.12）更常见（P分别为0.001和0.02）。安慰剂组第1天出血情况比药物组更常见（34例中有3例），药物组无出血。接受硫糖铝治疗的患者第1天食物不耐受情况（34例中有2例）比安慰剂组（34例中有9例）或克林霉素组（33例中有11例）少见（P = 0.02）。三组在夜间醒来、口臭、耳痛、恶心和呕吐发作次数上无显著差异。
该试验表明，局部应用硫糖铝和克林霉素是安全药物，无重要不良反应，可显著减轻儿童扁桃体切除术后的疼痛，并帮助他们更快恢复正常生活。
伊朗临床试验注册中心注册号：IRCT201303209014N16。
