Randomized double-blind trial comparing oral paracetamol and oral nonsteroidal antiinflammatory drugs for treating pain after musculoskeletal injury

Ann Emerg Med. 2005 Oct;46(4):352-61. doi: 10.1016/j.annemergmed.2005.01.023.


Study objective: We investigate the efficacy and safety of oral paracetamol compared with oral nonsteroidal antiinflammatory drugs or combination therapy in relieving pain after blunt limb injury in an emergency department (ED).

Methods: This was a double-blind, randomized, controlled study in an ED of a university hospital in the New Territories of Hong Kong. Three hundred adult patients with painful isolated limb injuries were enrolled. Primary outcome measures were pain relief at rest and with limb movement, adverse events, and patient satisfaction.

Results: There was no statistical difference in the mean reduction in pain score between any of the combinations at any point, although combination therapy was the first to reach a clinically significant reduction in pain score (<13 mm), and diclofenac-paracetamol combinations consistently produced a greater reduction in mean pain score than either nonsteroidal antiinflammatory drugs or paracetamol alone. All combinations appeared to be safe, although more patients receiving diclofenac-paracetamol combination complained of abdominal pain. The median patient satisfaction scores were poor.

Conclusion: In the doses, frequencies, and routes of administration used for this study, any analgesic benefit of oral paracetamol-nonsteroidal antiinflammatory drug combinations over single nonsteroidal antiinflammatory drugs or paracetamol treatment is small and of doubtful clinical significance. Nonsteroidal antiinflammatory drugs, paracetamol, and diclofenac-paracetamol combinations appeared equally safe in the management of musculoskeletal pain.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / administration & dosage*
  • Acetaminophen / adverse effects
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Diclofenac / administration & dosage
  • Diclofenac / adverse effects
  • Dizziness / chemically induced
  • Female
  • Humans
  • Indomethacin / administration & dosage
  • Indomethacin / adverse effects
  • Male
  • Musculoskeletal Diseases / complications*
  • Nausea / chemically induced
  • Pain / diagnosis
  • Pain / drug therapy*
  • Pain / etiology*
  • Pain Measurement / drug effects
  • Patient Satisfaction
  • Treatment Outcome
  • Vomiting / chemically induced
  • Wounds and Injuries / complications*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Diclofenac
  • Acetaminophen
  • Indomethacin