A placebo‐controlled model for assaying systemic analgesics in children

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 ½, 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 smileyface 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° 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. Clinical Pharmacology and Therapeutics (1993) 53, 593–601; doi: 10.1038/clpt.1993.75