Assessment of ADRS in Patients Undergoing NSAID Treatment in a Tertiary Care Centre

Abstract

Non-steroidal anti-inflammatory drugs are extensively prescribed for pain and inflammation management in dental care. However, NSAIDs are associated with an important danger of adverse drug reactions, mainly affecting the gastrointestinal, renal, and cardiovascular systems. This study intended to assess the incidence, pattern, severity, and causality of ADRs related to NSAID use in patients attending a tertiary care dental hospital.A prospective observational study was conducted in the departments of orthodontics, prosthodontics, and oral surgery at a tertiary care teaching dental hospital in North India. Patients aged 18–70 years receiving NSAIDs for dental pain were enrolled after informed consent. Demographic data, NSAID prescription details, and medical history were recorded. ADRs were monitored during follow-up visits on Day 7 and Day 10. Pain intensity was assessed using the Visual Analogue Scale.

Among the study participants, 39 ADR cases (13%) were reported. Ketorolac was the most frequently implicated drug, responsible for 35 ADRs (11.67%), followed by Diclofenac with 4 ADRs (1.33%). Other NSAIDs like Ibuprofen, Indomethacin, Aceclofenac, and Acetaminophen showed no ADRs. The most common adverse events were gastrointestinal symptoms, including nausea (32 cases), heartburn (10 cases), abdominal pain (10 cases), and gastrointestinal bleeding (8 cases). The mean VAS score reduced from 5.53 ± 1.12 at baseline to 3.46 ± 1.4 at Day 10, representing significant pain relief. ADR severity analysis exposed that most reactions were moderate (mean Hartwig and Siegel score: 3.04 ± 0.94). A statistically significant association was observed between the type of NSAID and ADR occurrence (χ² = 180.931; P < 0.001).This study shows that while NSAIDs are effective in managing dental pain, their use is associated with a substantial risk of gastrointestinal and systemic ADRs, particularly with Ketorolac.