Summary of clinical trials of ibuprofen in the treatment of dental pain
This is a selection of clinical trials representative of the published work for this indication.
1. Analgesic dose-response relationship of ibuprofen 50, 100, 200, and 400 mg after surgical removal of third molars
Study design
The effectiveness of increasing single doses of ibuprofen (50, 100, 200 and 400 mg) was determined in 212 evaluable patients following surgical removal of an impacted third molar. The dose was taken when postoperative pain became moderate or severe. Pain intensity and relief were assessed over 6 hours post-dose. If pain relief was inadequate, paracetamol was available as rescue analgesia.
This study was:
 randomised
double-blind
placebo-controlled
Summary of results
All doses of ibuprofen were significantly superior to placebo. There was a clear relationship between pain relief and the dose of ibuprofen. Overall, the 400 mg dose was associated with greatest pain relief, longest duration of analgesic effect and the least use of rescue analgesia. Reported adverse events were mild and transient, with no significant differences between placebo or ibuprofen doses.
Reference
Schou S et al. Analgesic dose-response relationship of ibuprofen 50, 100, 200, and 400 mg after surgical removal of third molars: a single-dose, randomized, placebo-controlled, and double-blind study of 304 patients. J Clin Pharmacol 1998;38:447-54
2. Analgesic efficacy of low-dose ibuprofen in dental extraction pain
Study Design
Single doses of ibuprofen (100, 200 and 400 mg) were compared with aspirin 650 mg and placebo in 227 evaluable patients undergoing surgical removal of 1 - 4 impacted molars. The dose was taken when postoperative pain reached moderate intensity. Pain intensity and relief were assessed at regular intervals for 6 hours post-dose. Rescue analgesia was available.
This study was:
randomised
double-blind
placebo-controlled
Summary of results
All doses of ibuprofen and aspirin were significantly superior to placebo. Ibuprofen 200 and 400 mg were clinically superior to aspirin though the differences in pain scores were small. Rescue analgesia was taken within 6 hours by 96% of patients given placebo compared with 73% with aspirin and 59%, 67% and 74% with ibuprofen 400 mg, 200 mg and 100 mg. There were no significant differences between the groups in the frequency of adverse effects.
Reference
Jain AK et al. Analgesic efficacy of low-dose ibuprofen in dental extraction pain. Pharmacotherapy 1986;6:318-22
3. Ibuprofen and acetaminophen in the relief of acute pain
Study Design
Single doses of ibuprofen 400 mg and paracetamol 1000 mg were compared in 184 evaluable patients undergoing surgical removal of impacted teeth. The dose was taken when post-surgical pain reached moderate intensity. Pain intensity and relief were assessed at regular intervals for 6 hours post-dose. Rescue medication was available.
This study was:
randomised
double-blind
placebo-controlled
Summary of Results
Both analgesics were superior to placebo; ibuprofen was significantly more effective than paracetamol in relieving pain. Rescue medication was required within 4 hours by 64% given placebo, 50% taking paracetamol, and 30% with ibuprofen. Adverse effects were reported by 11% with placebo, 17% with paracetamol and 8% with ibuprofen; none were serious.
Reference
Cooper SA et al. Ibuprofen and acetaminophen in the relief of acute pain: a randomized, double-blind, placebo-controlled study. J Clin Pharmacol 1989;29:1026-30
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