European Journal of Biomedical and Pharmaceutical Sciences

A STUDY ON MONITORING ADVERSE DRUG REACTIONS ASSOCIATED WITH THE USE OF OPIOID ANALGESICS IN POST OPERATIVE PATIENTS

Mohammed Fareedullah*, Syeda Zuleqaunnisa, Fathma Mohammed, Ghousiya Noorie, Mir Moinuddin Ali Khan, Mohammed Sohail Ali and Syed Nusrath Farees

ABSTRACT

Opioid analgesics are the most frequently used drug for the management of pain in post- operative and expected to have increased risk of adverse drug reactions during the hospitalization. A prospective observational study was carried out in a teaching hospital over a period of 4 months and 100 patients were enrolled. Tramadol (100 mg/ml, IV, BD or TID) and Fentanyl (100 mg/ml, IV, TID or BD) were administered in the patients. Detection of the ADR was done using Naranjo’s causality assessment scale. The severity of the ADRS was assessed using the Hartwig and Siegel scale. ADRs were identified in 16% of patients. Majority of the ADRs were seen in the young patients of age group 21- 40 years. The most common ADR among the patients is nausea (18.75%) followed up by the gastric irritation, nausea and vomiting, purities, dyspnea, urinary retention which are 12.5% each. In this study majority of the ADRs were because of the use of the tramadol 15 (based on the causality assessment Naranjo scale 8 (50%) were probable, 5 (31.25%) doubtful, 2 (12.5 %) possible, 1 (6.25) probable. The severity appeared to be mild in 11 (68.75%), moderate in 3 (12%) & severe in 2 (12.5%) patients. ADRs were managed by reduction in dose or by drug withdrawal. Mortality or disabilities due to ADRs are not identified in our study. All patients recovered and discharged at stable condition. The present finding provides the perspective with regard to the ADRs reported with the opioid analgesics. This would help the healthcare practitioners for safe and more rational use of it in the management of the pain in the post-operative patients.

Keywords: Adverse drug reaction (ADR), opioid analgesics, post-operative patients, causality assessment, severity assessment, rational use of opioids, pain.