A randomized, clinical trial comparing oral celecoxib 200 mg, celecoxib 400 mg, and ibuprofen 600 mg for acute pain.
OBJECTIVE
Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor used to treat pain. The objective of this study was to compare the efficacies of celecoxib and ibuprofen for the treatment of acute pain. The null hypothesis was that no difference between celecoxib and ibuprofen exists.


METHODS
The study was a prospective, randomized, double-blind, controlled clinical trial. After consent, patients rated their pain on a 100-mm visual analog scale (VAS) and categorical intensity pain scale. Patients were then randomized to receive 200-mg or 400-mg celecoxib or 600-mg ibuprofen (all orally). Patients were contacted 5 hours after receiving study medication when a second VAS score was recorded, along with categorical pain intensity, pain relief score, side effects, and number of rescue medications taken. The main outcome measures were change in visual analog pain and categorical pain intensity scores, and pain relief scores, at five hours.


RESULTS
One hundred ten patients were evaluated and 105 were enrolled. Thirty-four received celecoxib 200 mg, 32 received celecoxib 400 mg, and 39 received ibuprofen 600 mg. Ninety-one were available for the five-hour VAS and 88 for the five-hour categorical pain intensity and pain relief analysis: The two patients who were unable to read a VAS were excluded, and two enrolled patients withdrew prior to medication. One patient was excluded because his injury was a fracture, and therefore did not meet the inclusion criteria. There was no statistical difference among the treatment groups in age, time from injury to medication, initial VAS score, percent lost to follow-up, or treatment with adjunctive therapy. There was no statistical difference in change of VAS among the groups at five hours: ibuprofen 600 mg (-23.8 mm [95% CI = -31.56 mm to -16.1 mm] [n = 32]), celecoxib 200 mg (-16.1 mm [95% CI = -24.3 mm to -7.98 mm] [n = 31]), and celecoxib 400 mg (-12.4 mm [95% CI = -23.1 mm to -1.8 mm] [n = 30]) (p = 0.16). There was no significant difference between the groups, at five hours, in change of categorical pain intensity (p = 0.11) or pain relief scores (p = 0.059), though the pain relief scale approached significance favoring ibuprofen.


CONCLUSIONS
No significant difference exists among emergency department (ED) patients treated for acute pain, at five hours, with celecoxib 200 mg, celecoxib 400 mg, or ibuprofen 600 mg, though the power of the study to detect a change was low, 36%. However, the magnitude of pain relief for celecoxib, coupled with the cost of the medication, questions its use in the immediate ED setting.
Salo
David F
DF
Department of Emergency Medicine, Newark Beth Israel Medical Center, NJ 07112, USA. ds1122@aol.com
Lavery
Robert
R
Varma
Vikram
V
Goldberg
Jennifer
J
Shapiro
Tara
T
Kenwood
Alan
A
D000208:Acute Disease; D000328:Adult; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008297:Male; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011720:Pyrazoles; D013449:Sulfonamides / Q000008:administration & dosage* / Q000627:therapeutic use*; D013997:Time Factors
D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D007052:Ibuprofen