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Randomized Controlled Trial
. 2011 Sep 29:37:48.
doi: 10.1186/1824-7288-37-48.

A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians

Nicolino Ruperto  1 , Luigi Carozzino, Roberto Jamone, Federico Freschi, Gianfranco Picollo, Marcella Zera, Ornella Della Casa Alberighi, Enrica Salvatori, Alessandra Del Vecchio, Paolo Dionisio, Alberto Martini
Affiliations
Randomized Controlled Trial

A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians

Nicolino Ruperto et al. Ital J Pediatr. .

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.

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Figures

Figure 1
Figure 1
Flow diagram of the progress of enrolled patients through the trial.
Figure 2
Figure 2
Mean (95% CI) change over time course of pain as assessed by children with the Children's Sore Throat Pain (CSTP) Thermometer with values going from 0 mm (no pain) to 200 mm (very severe pain). P values refers to the as Sum of Pain Intensity Differences (SPID) with 95% CI for the comparison paracetamol versus placebo.
Figure 3
Figure 3
Mean (95% CI) change over time course of pain as assessed by parents (Panel A) or investigators (Panel B) with the Sore Throat Pain Intensity (STPI) with values going from 0 mm (no difficulty in deglutition) to 100 mm (a lot of difficulties in deglutition). P values refers to the as Sum of Pain Intensity Differences (SPID) with 95% CI for the comparison paracetamol versus placebo.
See this image and copyright information in PMC

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