Research Article
Open Access
Safety Concerns and Pharmacovigilance Insights in Pain Management for Fracture Patients
Zhang Guo1*, Jiang Zhu2, Li Wang2, Huang Liu2, Zhuang Li2
Center for Structural Pharmacology and Therapeutics Development, Sir Run Run Shaw Hospital,
Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, MA, USA
Zhang Guo. Safety Concerns and Pharmacovigilance Insights in Pain Management for Fracture Patients. Int.J. MediPharm Res. 2024,10(2),pp 19-24
Abstract
Background: Analgesic medications, while effective for pain relief, are associated with a range of
side effects from mild discomfort to severe complications. Following surgical repair of fractures, analgesics are
routinely prescribed, yet data on their adverse events specifically in ankle and hind foot fractures remain limited.
This study aims to evaluate patterns of oral analgesic prescriptions post-surgery for these fractures, document the
occurrence of adverse events, and identify potential risk factors.
Methods: The study recruited 19 adult patients with traumatic ankle and hind foot fractures at a tertiary care
hospital. Prescribed oral analgesics at discharge and at the one-week follow-up were recorded. Potential adverse
events were monitored at one- and two-week follow-ups. Incidence rates were calculated, and relationships
between adverse events, age, and gender were analyzed using logistic regression and correlation assessments.
Results: The overall incidence of adverse events among the study population was 1.1 events per person-year
across the 1- and 2-week follow-ups. Analgesic-specific analysis identified high-risk agents: acetaminophen
alone or combined with diclofenac or tramadol was associated with increased cardiovascular risks (N=4.21%).
Combinations such as naproxen with tramadol, orphenadrine with acetaminophen, and diclofenac were linked to
gastrointestinal and central nervous system complications (N=3.16%).
Conclusion: This study provides initial evidence on adverse event incidence linked to oral analgesic prescriptions
for ankle and hind foot fractures, aiding in safer analgesic selection. Ongoing research will further refine patientspecific
pain management strategies and help establish fracture-specific protocols to optimize safety and efficacy.
Keywords
Analgesics; Adverse events; Ankle fractures; Hind foot fractures; Pain management; Trauma.