药物保健与健康系统杂志
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Adverse Events in Analgesia for Fractures: A Study for Pharmacovigilance

Zehra Abdul Muhammad*, Tashfeen Ahmad, Yasir Mohib, Rizwan Haroonrashid, Naveed Baloch

Background: Analgesics are known to have many side effects with mild to serious impacts. After fracture surgery analgesics are commonly prescribed, but literature on their adverse events specifically in ankle and hind foot fractures is scanty. This study aimed to explore the current practice of prescribing oral analgesics for ankle, and hind foot fractures post-surgery, the incidence of adverse events, and possible risk factors.

Methods: The study was initiated in June 2022. A total of 19 adult patients with traumatic ankle and hind foot fractures were recruited at a tertiary care hospital. Oral analgesics prescribed at discharge and 1-week follow-up were stratified with potential adverse events recorded at 1- and 2-week follow-ups respectively. Adverse events incidence was calculated. The relationship between adverse events, age, and gender was assessed by logistic regression and correlation coefficients.

Results: The overall adverse events incidence in ankle and hind foot fractures was 1.1 events/people-year recorded at 1 and 2 weeks follow-ups. On stratification, high-risk analgesics identified are acetaminophen exclusively or in combination with diclofenac or tramadol predisposing to cardiovascular risk (N=4.21%). Naproxen combined with tramadol, orphenadrine added acetaminophen, or diclofenac predisposing to gastrointestinal and central nervous system complications (N=3.16%).

Conclusion: Current data on adverse event incidence and stratification to prescribed oral analgesics in ankle and hind foot fractures could be helpful in the optimal safe analgesics selection. Further data from the ongoing study will provide us with better insight into the safe analgesic selection and establishing a fracture-specific optimal pain management protocol as per patient needs.