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A placebo-controlled model for assaying systemic analgesics in children
1Medical Department, Whitehall Laboratories, Inc., New York, NY 10017.
Insights
This study found that ibuprofen and acetaminophen are effective pain relievers for children with sore throats. The sore throat pain model is a reliable method for testing pediatric analgesics.
Area of Science:
- Pediatric Pharmacology
- Pain Management
- Clinical Trial Methodology
Background:
- Assessing analgesic efficacy in children requires validated pain models.
- The sore throat pain model offers a potential method for evaluating systemic analgesic agents in pediatric populations.
Purpose of the Study:
- To evaluate the sore throat pain model's sensitivity in assessing systemic analgesic agents in children.
- To compare the efficacy of ibuprofen and acetaminophen against a placebo for treating acute sore throat pain in children aged 2 to 12 years.
Main Methods:
- A double-blind, placebo-controlled, single-dose parallel study involving 116 children (2-12 years) with acute sore throat.
- Participants received ibuprofen (10 mg/kg), acetaminophen (15 mg/kg), or placebo.
- Pain intensity and relief were assessed by children, parents, and pediatricians using validated scales over 6 hours.
Main Results:
- Both ibuprofen and acetaminophen demonstrated significantly greater efficacy than placebo in reducing sore throat pain, as rated by children, parents, and pediatricians (p < 0.05).
- Active treatments also significantly reduced elevated oral temperatures in children.
- No treatment-related adverse effects were reported.
Conclusions:
- The sore throat pain model is a sensitive and reliable assay for identifying analgesic activity in children.
- Ibuprofen is confirmed as an effective analgesic for treating acute sore throat pain in pediatric patients.
Abstract:
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.