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


  • Prashant Hombal Department Of General Surgery, J. N. Medical College, KLE University, Belagavi, Karnataka
  • Anupama M. Gudadappanavar Department Of Pharmacology, J. N. Medical College, KLE University, Belagavi, Karnataka
  • Avinash Kavi Department Of Community Medicine, J. N. Medical College, KLE University, Belagavi, Karnataka




Diclofenac, Paracetamol, Postoperative pain, Tramadol


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 8th 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.






Original Research Articles