Sandesh P. Kamdi1,* & Prashant Palkar2
1

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of single dose intramuscular injection of diclofenac sodium and paracetamol fixed dose combination. DESIGN: Postmarketing surveillance study. SETTING: Private orthopedic hospitals in India. SUBJECTS: One hundred eighty nine patients between 13-75 years with moderate to severe pain following orthopedic surgery. INTERVENTION: 3ml injection of fixed dose combination of diclofenac sodium 75mg and acetaminophen 225mg (Dolentia-P® injection). METHODS: Pain assessment was performed using 10cm visual analogue scale (VAS). The primary efficacy outcome measures were onset of action, sum of pain intensity differences and pain relief, whereas secondary efficacy variables included number of patients experiencing pain at the site of administration, global assessment of the study medication was assessed by the patients and physician at the end of the trial. RESULTS: Mean pain intensity differences assessed on 10 cm VAS were significantly better at 15 minutes, 1, 4, 8, 12 and 24 hours (p<0.0001). At baseline, the pain score at VAS was 7.47±1.13, which at the end of 15 minutes was found to be 5.78±1.55. Similarly, pain score after 1, 4, 8, 12 and 24 hour was found to be 4.91±1.89, 3.96±2.03, 3.10±1.85, 2.27±1.80 and 2.02±1.72 respectively. There was a significant (p<0.0001) reduction in mean pain score at all the time points. Complete and partial pain relief was observed in 75.28% and 24.71% patients respectively. Study medication was well tolerated with no incidence of systemic adverse effects noticed throughout the study. CONCLUSION: The intramuscular injection of diclofenac sodium and paracetamol fixed dose combination is effective and safe in acute postoperative pain management. Keywords: Diclofenac Sodium, Acetaminophen, DOLOR study, Pain, Efficacy