Objective: To assess the efficacy of paracetamol in comparison with diclofenac sodium.
Methods: Between February - November 2006, a prospective, double blinded, parallel group study of 100 patients suffering from first or second degree lateral ankle sprain within 48-hours of admission in Tepecik Education and Research Hospital, Izmir, Turkey. Patients with bilateral injury, ipsilateral knee injury, third degree sprain, previous sprain within 6 months, and ankle pain less than 45 according to visual analogue score (VAS) were excluded. Patients rated pain on a 100 VAS, representing 0 no pain, 100 maximal pain. After enrollment, patients were randomized (1:1) with diclofenac sodium 150 mg/day or paracetamol 1500 mg/day for 5 days. Clinical assessments were carried out at baseline; on second, tenth days, and sixth week (end of study). In each visit, VAS and adverse effects of medication were questioned.
Results: The mean VAS of the diclofenac group was 81 and 82.3 with paracetamol group at the first visit. These scores decreased to 20.7, 9.9, 4.6 in diclofenac group and 11.9, 6.3, 3 in paracetamol group at the second, tenth days and last examination. Similar reductions in pain were observed at the end of study (p>0.05) in both groups. However, cases treated by paracetamol group showed accelerated decrease in VAS at day 2 and 10 in comparison with diclofenac group (p<0.05). Of the ankle range of motion, there was a similar improvement in both groups (39.6 degrees, 37.5 degrees) (p>0.05). The incidence of gastrointestinal adverse effects on diclofenac group was much more than the paracetamol group, however, there was no significant difference (p>0.05).
Conclusion: It was concluded that diclofenac sodium and paracetamol are effective and well tolerated as a short term treatment alternatives for acute ankle injuries.