title: A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: IRCCS G Gaslini, Pediatria II, Reumatologia, PRINTO, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it
authors.forename: Nicolino
authors.initials: N
authors.lastname: Ruperto
authors.forename: Luigi
authors.initials: L
authors.lastname: Carozzino
authors.forename: Roberto
authors.initials: R
authors.lastname: Jamone
authors.forename: Federico
authors.initials: F
authors.lastname: Freschi
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Picollo
authors.forename: Marcella
authors.initials: M
authors.lastname: Zera
authors.forename: Ornella
authors.initials: O
authors.lastname: Della Casa Alberighi
authors.forename: Enrica
authors.initials: E
authors.lastname: Salvatori
authors.forename: Alessandra
authors.initials: A
authors.lastname: Del Vecchio
authors.forename: Paolo
authors.initials: P
authors.lastname: Dionisio
authors.forename: Alberto
authors.initials: A
authors.lastname: Martini
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000208:Acute Disease; D000284:Administration, Oral; D000553:Ambulatory Care; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D006801:Humans; D007660:Ketoprofen / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008239:Lysine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010372:Pediatrics; D010612:Pharyngitis / Q000150:complications*; D010919:Placebos; D013997:Time Factors; D014069:Tonsillitis / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D000082:Acetaminophen; C029946:ketoprofen lysine; D007660:Ketoprofen; D008239:Lysine