Topical Ketoprofen Versus Placebo in Treatment of Acute Ankle Sprain in the Emergency Department

Foot Ankle Int. 2016 Sep;37(9):989-93. doi: 10.1177/1071100716650530. Epub 2016 May 19.


Background: Topical agents have been shown to be effective in soft tissue injuries and commonly used in outpatient clinics. However, the data regarding topical agents in the emergency department is insufficient, and they are not used often in the emergency department setting. The present study aimed to compare the effect of 2.5% topical ketoprofen (gel form) to placebo in patients presenting with ankle sprain to the emergency department.

Methods: Patients presenting with ankle sprain composed the study population. Study patients were randomized into 2 study arms: 2.5% ketoprofen gel and placebo administered over a 5-cm area locally. Pain alleviation was measured by visual analog scale at 15 and 30 minutes. A total of 100 patients were included in the final analysis.

Results: The median pain reduction in ketoprofen and placebo groups at 15 minutes was 27 (19.8-33.4) and 9 (7.6-17), respectively. The median pain reduction at 30 minutes for both groups was 42 (36-50.8) and 20 (17.6-24.4), respectively. Pain improvement either at 15 minutes (median difference: 16 [9-22]) or 30 minutes (median difference: 21 [15-27]) was better in the ketoprofen group than placebo. There were no adverse effects in either group.

Conclusion: Ketoprofen gel was superior to placebo at 30 minutes in alleviating pain secondary to ankle sprain in the ED with a high safety profile. Further studies are needed concerning the effect of ketoprofen gel for long-term effects.

Level of evidence: Level I, high quality prospective randomized study.

Keywords: ankle sprain; emergency department; ketoprofen; topical.

MeSH terms

  • Ankle Injuries / drug therapy*
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Double-Blind Method
  • Emergency Service, Hospital
  • Humans
  • Ketoprofen / administration & dosage*
  • Ketoprofen / adverse effects
  • Ketoprofen / analogs & derivatives*
  • Ketoprofen / pharmacology
  • Pain / drug therapy*
  • Pain Measurement
  • Prospective Studies
  • Sprains and Strains / drug therapy*
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • ketoprofen topical gel
  • Ketoprofen