Schachtel B P, Thoden W R
Medical Department, Whitehall Laboratories, Inc., New York, NY 10017.
Clin Pharmacol Ther. 1993 May;53(5):593-601. doi: 10.1038/clpt.1993.75.
To assess the sore throat pain model in children as an assay for systemic analgesic agents in children under double-blind, placebo-controlled conditions, we conducted a single-dose parallel study that compared 10 mg/kg ibuprofen (n = 39), a new analgesic agent for children, and 15 mg/kg acetaminophen (n = 38), an approved analgesic for children, to placebo (n = 39) in children from 2 to 12 years of age with acute sore throat. At 1/2, 1, 2, 3, 4, 5, and 6 hours (2 hours in the pediatrician's office followed by 4 hours at home), children assessed pain intensity with a pain thermometer and pain relief with a smiley-face scale. The parent and pediatrician assessed pain intensity and change in pain; the parent also provided an overall evaluation at 6 hours. The children rated ibuprofen and acetaminophen as significantly effective compared with placebo (p < 0.05) on both scales at most posttreatment time points and overall. The parent and pediatrician also rated both active medications as significantly different from placebo on both of their scales (p < 0.05) at several time points and overall. On the parent's overall evaluation, ibuprofen was rated as effective compared with placebo (p < 0.05). Both active agents significantly (p < 0.05) reduced oral temperature in children with baseline temperatures > 99 degrees F. No treatment-related adverse effects were observed. We conclude that the sore throat pain model is a sensitive assay for identification of the activity of oral analgesic drugs in children and that ibuprofen is an effective analgesic in children.
为了在双盲、安慰剂对照条件下评估儿童咽喉痛疼痛模型作为儿童全身性镇痛药的一种测定方法，我们进行了一项单剂量平行研究，在2至12岁患有急性咽喉痛的儿童中，将10mg/kg布洛芬（n = 39，一种新型儿童镇痛药）、15mg/kg对乙酰氨基酚（n = 38，一种已获批准的儿童镇痛药）与安慰剂（n = 39）进行比较。在1/2、1、2、3、4、5和6小时（在儿科医生办公室2小时，随后在家4小时），儿童用疼痛温度计评估疼痛强度，并用笑脸量表评估疼痛缓解情况。家长和儿科医生评估疼痛强度和疼痛变化；家长还在6小时时提供总体评价。在大多数治疗后时间点及总体上，儿童对布洛芬和对乙酰氨基酚的评价在两种量表上均显著优于安慰剂（p < 0.05）。家长和儿科医生在几个时间点及总体上对两种活性药物的评价在他们各自的量表上也均显著不同于安慰剂（p < 0.05）。根据家长的总体评价，布洛芬与安慰剂相比被评为有效（p < 0.05）。两种活性药物均显著（p < 0.05）降低了基线体温> 99华氏度儿童的口腔温度。未观察到与治疗相关的不良反应。我们得出结论，咽喉痛疼痛模型是一种用于识别儿童口服镇痛药活性的敏感测定方法，并且布洛芬是儿童有效的镇痛药。
