ABSTRACT
Purpose Thrombophlebitis is a frequent intravenous (IV) therapy consequence. Topical heparin for seven days is used as a treatment for thrombophlebitis. This study was performed to evaluate the clinical safety and effectiveness of the combination of heparin sodium & benzyl nicotinate (Thrombophob Ointment, manufactured by Zydus Healthcare Ltd., Ahmedabad, India) in thrombophlebitis patients in India. Methods A study carried out by 118 Indian doctors examined 2002 thrombophlebitis patients from 2016-2023, prescribing ointment containing heparin sodium and benzyl nicotinate. Patients were followed up on day three and day seven after starting the treatment, and safety and effectiveness were recorded, including adverse events. Result A total of 2002 patients were included in the study and males were predominant (58.15%). IV fluids (60.58%) were the leading cause of thrombophlebitis. The study found notable improvements in key markers of venous health over time. Compared to baseline, patients experienced significantly reduced severity of phlebitis, shorter venous lesion lengths, and lower pain and tenderness scores by both day 3 and day 7 (p<0.001 for all comparisons). Furthermore, these improvements continued between day 3 and day 7, indicating sustained positive effects (p<0.001 for all comparisons). After the application of the ointment, very few patients experienced adverse effects (0.25% on day three and 0.05% on day seven). Treatment effectiveness was excellent in 72% of patients, and treatment safety was excellent in 93% of patients. Conclusion The ointment containing heparin sodium and benzyl nicotinate was well tolerated and efficacious in the treatment of thrombophlebitis in Indian patients.
ABSTRACT
Introduction Pain is a major health issue globally. Etoricoxib, a highly selective COX-2 inhibitor, given orally, has been found to be efficacious and safe in the management of acute and chronic pain. Oral etoricoxib has been extensively studied; however, there is a lack of research exploring the use of etoricoxib via alternative routes, specifically intramuscular (IM) injection. This study aimed to evaluate the effectiveness and safety of an innovative and novel formulation of IM etoricoxib injection 90 mg/mL in the management of patients with acute pain in India. Method This was a real-world, multicenter, retrospective, observational study to investigate the effectiveness and safety of IM etoricoxib injection in the management of patients with acute pain in India (outpatient setting). The clinical data of 383 patients from 42 centers across India were collected from November 2022 to April 2023. Following approval from the site investigator, comprehensive patient-level information encompassing demographic and clinical variables as well as comorbidities was collected and entered into a case report form. Approval from the Independent Ethics Committee (IEC) and Institutional Review Board (IRB) was sought. The safety and effectiveness at 30 minutes and 60 minutes of IM etoricoxib injection were then analyzed. Results Among the studied patients, etoricoxib was used for the management of knee arthritis, fracture, post-traumatic pain, postoperative cases, acute back pain, back injury, torn ligament, and muscle strain and sprain. Of 383 patients, 98.17% had moderate-to-severe pain at baseline on the visual analogue scale (VAS) (0 being no pain and 10 being severe unbearable pain). The percentage of patients with severe pain reduced to only 6.78% and 4.17% at 30 minutes and 60 minutes, respectively. The improvement in the VAS score was statistically significant from baseline to 30 minutes and 60 minutes, and at 60 minutes compared to 30 minutes (p < 0.0001). More than half the patients (56.91%) had no pain at the site of the injection. Most of the doctors (70.23%) opined that the IM etoricoxib injection was better than their currently used NSAID injections for pain relief. Only 12.79% of patients required rescue analgesia post-IM etoricoxib injection. IM etoricoxib injection was well tolerated as 98.69% of the patients did not experience or report any adverse events post-IM injection. Conclusion This real-world, multicenter, retrospective, observational study across India demonstrated that the innovative and novel formulation of etoricoxib (90 mg/mL IM injection) was effective and well-tolerated in the management of acute pain. Overall, this study provides valuable insights into the real-world effectiveness and safety of IM etoricoxib injections, suggesting it could be a promising therapy for the management of acute pain for optimal patient benefit.
