ketoprofen-lysine and Pharyngitis

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.. A 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.. 97 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.. A 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.

Topics: Acetaminophen; Acute Disease; Administration, Oral; Ambulatory Care; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Double-Blind Method; Family Practice; Female; Humans; Ketoprofen; Lysine; Male; Pain; Pediatrics; Pharyngitis; Placebos; Time Factors; Tonsillitis; Treatment Outcome

Pharyngodynia, or sore throat, is one of the symptoms most frequently reported by patients to primary care physicians.. The purpose of this study was to compare the efficacy and tolerability of mouthwash formulations of ketoprofen lysine salt (KLS), an anti-inflammatory agent, and benzydamine hydrochloride (BH), a local anesthetic, in patients with acute inflammation of the pharyngeal cavity.. In this randomized, multicenter, parallel-group, single-blind study, patients (who were blinded) were assigned to receive undiluted BH 15 mL (22.5 mg) or KLS 10 mL (160 mg) diluted in 100 mL of water. Both agents were gargled twice daily until pain remission or up to 7 days. A physical examination of the oropharyngeal cavity was performed, and severity of edema and hyperemia was assessed after 3 days of treatment and, if symptoms had not resolved, after pain remission.. Of the 241 patients (120 KLS, 121 BH), 239 were included in the safety analysis and 232 were in the intent-to-treat population. The differences between groups in the duration of analgesic effect after the first dose of drug and the time course of pain were found to be statistically significant (P = 0.006 and P = 0.017, respectively), favoring KLS. Adverse drug-related effects reported included numbness of the tissues in the oral cavity, sensation of tingling in the tissues in the oral cavity, dry mouth, thirst, and nausea. A significantly greater proportion of BH-treated patients reported adverse events (P = 0.001 for all adverse events and drug-related adverse events).. KLS mouthwash exerts a significantly longer first-application analgesic action with significantly greater local tolerability than BH in patients with pharyngeal pain of inflammatory and/or infectious origin.

Topics: Adolescent; Adult; Aged; Analysis of Variance; Anti-Infective Agents, Local; Anti-Inflammatory Agents, Non-Steroidal; Benzydamine; Female; Humans; Ketoprofen; Lysine; Male; Middle Aged; Mouthwashes; Pain Measurement; Pharyngitis; Remission Induction; Single-Blind Method