Randomized clinical trial comparing the effect of paracetamol with diclofenac in combination with on request rescue analgesic tramadol: analgesic efficacy, safety and tolerability after abdominal surgery

Abstract

Background: The study was planned to assess the efficacy and safety of paracetamol in comparison with diclofenac for post-operative analgesic pain in patients undergoing elective abdominal surgery. This, randomized clinical trial was conducted in an institution of medical education and tertiary care centre.

Methods: 90 patients scheduled for elective abdominal surgery were assigned in a randomized manner in to two groups. Group P received 1 g paracetamol intravenously (IV) 8 hourly and group D received 75 mg intramuscular (IM) diclofenac 8^th hourly for 24 hr post‑operative period. The pain intensity was judged using pain visual analogue score (VAS) at time periods 2h, 4h, 6h, 12h, 18h and 24h post-surgery. Patient reported with a VAS pain score of greater than 3, a rescue analgesic IV tramadol 100 mg injection was given. The need of rescue analgesic, pain VAS, patient satisfaction score and adverse effects were recorded.

Results: The data was expressed in mean +/-SD and analysed using unpaired t test, chi-square test, followed by Fisher’s exact post-hoc test. Total tramadol requirement were not significantly different between paracetamol and diclofenac groups. Gastrointestinal side effects were present in 6.6% and 17.7% of patients receiving paracetamol and diclofenac respectively. Patient satisfaction score till administration of rescue analgesics showed statistically significant difference (p=0.043) between the groups.

Conclusions: Paracetamol is equally effective and safer which can be a practicable alternative compared to Diclofenac especially because of its highly encouraging risk benefit-ratio, which justify its role as a near-routine   management for post-operative pain.