Summary of clinical trials of ibuprofen in the treatment of sore throat
This is a selection of clinical trials representative of the published work for this indication.
1. Evaluation of ibuprofen vs. paracetamol analgesic activity using a sore throat pain model
Study design
Ibuprofen (400 mg three times a day) was compared with paracetamol (1000 mg three times a day) in 113 patients with at least moderately severe pain due to sore throat associated with tonsillopharyngitis. The duration of treatment was up to 2 days. Pain relief was assessed at intervals up to 6 hours post-dose and at the end of the study.
This study was:
 randomised
double-blind
Summary of results
Over the 6 hours following the first dose, ibuprofen was significantly superior to paracetamol when assessed by the reduction in pain intensity on swallowing, difficulty in swallowing and improvement in pain relief. Ibuprofen was also significantly superior according to global assessments by investigators and patients at 48 hours. The frequency of adverse effects was similar.
Reference
Boureau F et al. Evaluation of ibuprofen vs. paracetamol analgesic activity using a sore throat pain model. Clin Drug Invest 1999;17:1-8
2. Sore throat in the evaluation of mild analgesics
Study design
Single doses of ibuprofen 400 mg and paracetamol 1000 mg were compared with placebo in 120 patients with relatively severe pain due to sore throat associated with tonsillopharyngitis. Pain was assessed for 6 hours after the dose.
This study was:
randomised
double-blind
placebo-controlled
Summary of results
Both treatments were superior to placebo in relieving pain. Ibuprofen was significantly more effective than paracetamol from 2 hours to 6 hours, achieving a greater reduction in pain intensity and acting more quickly. Ibuprofen also reduced throat swelling significantly more than paracetamol. No adverse effects were reported.
Reference
Schactel BP et al. Sore throat in the evaluation of mild analgesics. Clin Pharmacol Ther 1988;44:704-11
3. A placebo-controlled model for assaying systemic analgesics in children
Study design
Single doses of ibuprofen 10 mg/kg and paracetamol 15 mg/kg were compared with placebo in 116 children (age 3.5 - 12.5 years) with sore throat pain of at least moderate severity associated with tonsillopharyngitis. Pain relief was assessed at intervals up to 6 hours post-dose.
This study was:
randomised
double-blind
placebo-controlled
Summary of results
Both treatments were superior to placebo, with pain relief evident 30 minutes after the dose. There was no difference between ibuprofen and paracetamol in pain relief for up to 6 hours, by pain scores or parental and investigators' assessments.
Reference
Schactel BP, Thoden WR. A placebo-controlled model for assaying systemic analgesics in children. Clin Pharmacol Ther 1993;53:593-601
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