Abstract
BackgroundTo evaluate the analgesic effect and tolerability of paracetamol syrup compared to placebo and ketoprofen lysine salt in children with pharyngotonsillitis cared by family pediatricians.MethodsA double-blind, randomized, placebo-controlled trial of a 12 mg/kg single dose of paracetamol paralleled by open-label ketoprofren lysine salt sachet 40 mg. Six to 12 years old children with diagnosis of pharyngo-tonsillitis and a Children's Sore Throat Pain (CSTP) Thermometer score > 120 mm were enrolled. Primary endpoint was the Sum of Pain Intensity Differences (SPID) of the CSTP Intensity scale by the child.Results97 children were equally randomized to paracetamol, placebo or ketoprofen. Paracetamol was significantly more effective than placebo in the SPID of children and parents (P < 0.05) but not in the SPID reported by investigators, 1 hour after drug administration. Global evaluation of efficacy showed a statistically significant advantage of paracetamol over placebo after 1 hour either for children, parents or investigators. Patients treated in open fashion with ketoprofen lysine salt, showed similar improvement in pain over time. All treatments were well-tolerated.ConclusionsA single oral dose of paracetamol or ketoprofen lysine salt are safe and effective analgesic treatments for children with sore throat in daily pediatric ambulatory care.
Highlights
To evaluate the analgesic effect and tolerability of paracetamol syrup compared to placebo and ketoprofen lysine salt in children with pharyngotonsillitis cared by family pediatricians
The sample size calculation was based on the results reported in a study comparing ibuprofen suspension (10 mg/kg) and paracetamol (15 mg/kg) to placebo in children with sore throat [6]
Initially randomized in the placebo and ketoprofen group, had a subsequent episode of pharyngotonsillitis, were both randomly re-allocated in the paracetamol group but were excluded from the analysis
Summary
To evaluate the analgesic effect and tolerability of paracetamol syrup compared to placebo and ketoprofen lysine salt in children with pharyngotonsillitis cared by family pediatricians. In pediatric population, should be a priority for clinicians. The importance of pain control in the pediatric population is widely recognized. There is still a lack of adequate clinical trials assessing the pharmacological effects of the oral analgesics commonly used in pediatric daily primary care [3,4]. Paracetamol (acetaminophen) is currently one of the most popular and widely used analgesic and antipyretic in children for the symptomatic treatment of acute pain and fever. From non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol does not produce gastrointestinal damage or untoward cardio-renal effects. Its anti-inflammatory activity is negligible [5]
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