Comparison between paracetamol, piroxicam, their combination, and placebo in postoperative pain management of upper limb orthopedic surgery (a randomized double blind clinical trial)

Abstract

BACKGROUND: Therapeutic superiority of a combination of Paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) over either drug alone remains controversial. We evaluated the efficiency of a combination of Paracetamol and Piroxicam versus each drug alone and also placebo in the management of postoperative pain, in patients who had undergone elective upper limb orthopedic surgery under general anesthesia. MATERIALS AND METHODS: A total of 100 patients were randomly divided into four groups to receive either intravenous (IV) infusion of Paracetamol, 15 mg/kg., intramuscular (IM) injection of Piroxicam 0.4 mg/kg., their combination or placebo. The pain scores were recorded at the first; second, fourth, sixth, twelfth, and 24 hours after Post Anesthesia Care Unit (PACU) admission. After the operation 0.1 mg/kg of morphine was administered, if the patient needed. RESULT: The means of the pain scores were 5.26 +/- 1.53, 4.09 +/- 0.88, 4.36 +/- 1.48, and 4.11 +/- 1.29, in groups A, B, C, and D, respectively, (Group A: received placebo; Group B: received both Paracetamol and Piroxicam; Group C received Piroxicam; Group D received Paracetamol). Except for differences between the mean pain scores in Groups B and D, the other differences were statistically significant (P value < 0.05). No adverse effect was reported in the four groups. CONCLUSION: IV infusion of 15 mg/kg Paracetamol used as a preventive may provide effective analgesia in comparison with IM 0.4 mg/kg Piroxicam or placebo. Addition of Piroxicam to Paracetamol has not much more benefit than Paracetamol alone, in reducing pain after upper limb orthopedic surgery.