A comparative evaluation of diclofenac and tramadol as post-operative analgesics along with causality and severity assessment of ADRs

ABSTRACT

Background: Diclofenac and Tramadol are well established analgesics for post-operative pain management, yet some adverse effects are associated with their use which govern their tolerability. The objective of the study was to evaluate the comparative efficacy of the two drugs and to assess the causality and severity of documented Adverse Drug Reactions (ADRs).Methods: An open labelled, prospective, interventional, simple randomized clinical study to compare efficacy and safety of diclofenac and tramadol was conducted by the Department of Pharmacology in collaboration with the Department of Surgery. Post-operative pain intensity was measured on Visual Analogue Scale (VAS). Causality and severity assessment of the recorded ADRs was done using WHO-UMC scale and modified Hartwig and Seigel Scale respectively.Results: A total of 211 patients underwent different surgeries. The most common surgery performed was mesh hernioplasty 78 (36.96%). VAS score was used as data to determine the analgesic efficacy of two drugs. Wilcoxon Signed Rank test showed significant reduction in pain on all days for each group individually while Mann Whitney U test compared both the groups and revealed that both the drugs i.e. diclofenac and tramadol were equally efficacious in reducing post-operative pain. Causality assessment showed that all the documented ADRs fall in POSSIBLE category while severity assessment revealed that all the ADRs were MILD in nature.Conclusions: Diclofenac and tramadol proved to be equi-effective in reducing post-operative pain . The study also emphasized that active surveillance of ADRs can lead to timely intervention and provide maximum benefit to the patient.