Efficacy and safety of celecoxib in the treatment of acute pain due to ankle sprain in a Latin American and Middle Eastern population.
Ankle sprains are common acute soft-tissue injuries. This 7-day open-label, multicentre, randomized study compared the efficacy and safety of celecoxib with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute ankle sprain with moderate-to-severe ankle pain in 278 patients. Patients received either celecoxib (400 mg loading dose followed by 200 mg twice daily) or standard doses of non-selective NSAIDs. The primary endpoint was a change in the patient's assessment of ankle pain on a 0 mm (no pain) - 100 mm (worst possible pain) visual analogue scale (VAS) at day 3 compared with baseline. From a baseline of 73 mm, mean VAS pain scores decreased to 29 and 32 mm in the celecoxib and non-selective NSAID groups, respectively. The lower limit of the 95% confidence interval for the treatment difference with regard to change from baseline was greater than the pre-established non-inferiority margin of -10 mm. Using an initial loading dose, celecoxib was at least as efficacious as non-selective NSAIDs in treating acute pain due to ankle sprain.
Facultad de Organización Deportiva, Universidad Autónoma de Nuevo León, Nuevo León, Mexico. eloy.cardenas@gmail.com <eloy.cardenas@gmail.com>
E
E
Cardenas-Estrada
L G
LG
Oliveira
H L
HL
Abad
F
F
Elayan
N
N
Khalifa
T
T
El-Usseini
D000208:Acute Disease; D016512:Ankle Injuries / Q000150:complications*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003710:Demography; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D006801:Humans; D007843:Latin America; D008877:Middle East; D017063:Outcome Assessment, Health Care; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D013180:Sprains and Strains / Q000150:complications*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib