Efficacy and safety of ketoprofen lysine salt mouthwash versus benzydamine hydrochloride mouthwash in acute pharyngeal inflammation: a randomized, single-blind study.
BACKGROUND
Pharyngodynia, or sore throat, is one of the symptoms most frequently reported by patients to primary care physicians.


OBJECTIVE
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Passàli
D
D
ENT Department, University of Siena Medical School, Policlinico Le Scotte, Italy. passali@unisi.it
Volonté
M
M
Passàli
G C
GC
Damiani
V
V
Bellussi
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000891:Anti-Infective Agents, Local / Q000009:adverse effects* / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use*; D001591:Benzydamine / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007660:Ketoprofen / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008239:Lysine / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000009:adverse effects* / Q000627:therapeutic use*; D010147:Pain Measurement; D010612:Pharyngitis / Q000188:drug therapy* / Q000503:physiopathology; D012074:Remission Induction; D016037:Single-Blind Method
D000891:Anti-Infective Agents, Local; D000894:Anti-Inflammatory Agents, Non-Steroidal; D009067:Mouthwashes; D001591:Benzydamine; C029946:ketoprofen lysine; D007660:Ketoprofen; D008239:Lysine