Explore (New York, N.Y.) · 2026
Effect of sesame oil and Nigella sativa oil on the prevention of amiodarone-induced phlebitis: a randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Nal Burcu, Sari Dilek, Astarcioğlu Mehmet Ali, Şen İsmail
Аннотация
BACKGROUND: Amiodarone, widely used in arrhythmia management, often causes phlebitis when administered via peripheral infusion. This study evaluated the effects of Nigella sativa oil and sesame oil in preventing amiodarone-induced phlebitis.
MATERIAL AND METHOD: The study was a randomized controlled trial with three parallel groups. This study included 108 patients who received amiodarone infusion in the coronary intensive care unit between November 2023 and August 2024. This three-arm, block-randomized controlled trial was conducted in line with CONSORT guidelines. Patients were randomly assigned to one of three groups: sesame oil (n = 36), Nigella sativa oil (n = 36), or control (n = 36). In the intervention groups, five drops of the respective oil were applied topically to a 10-cm area around the catheter site. The application was performed once before the infusion and then every 6 hours thereafter. The control group received no intervention. Patients were monitored hourly during the 26-hour infusion and every six hours for 48 hours after the infusion, for a total monitoring period of 74 hours. Phlebitis was assessed using the Visual Infusion Phlebitis Scale. This study was prospectively registered on ClinicalTrials.gov (NCT06030141) on November 15, 2023.
RESULTS: Phlebitis was observed in 25% of patients in the sesame oil group, 33.3% in the Nigella sativa oil group, and 80.6% in the control group. A significant difference in phlebitis severity was observed between the groups (p < 0.001), with the highest severity in the control group, the lowest in the sesame oil group, and moderate levels in the Nigella sativa oil group.
CONCLUSION: This study demonstrated that sesame and Nigella Sativa oils were effective in both preventing and reducing the severity of amiodarone-induced phlebitis. The use of sesame oil and Nigella sativa oil in peripheral intravenous catheter care may help reduce amiodarone-induced phlebitis, maintain vascular access integrity, and improve patient comfort. As natural, safe, and cost-effective agents, these oils can be readily incorporated into clinical nursing practice to enhance patient safety and quality of care.
MATERIAL AND METHOD: The study was a randomized controlled trial with three parallel groups. This study included 108 patients who received amiodarone infusion in the coronary intensive care unit between November 2023 and August 2024. This three-arm, block-randomized controlled trial was conducted in line with CONSORT guidelines. Patients were randomly assigned to one of three groups: sesame oil (n = 36), Nigella sativa oil (n = 36), or control (n = 36). In the intervention groups, five drops of the respective oil were applied topically to a 10-cm area around the catheter site. The application was performed once before the infusion and then every 6 hours thereafter. The control group received no intervention. Patients were monitored hourly during the 26-hour infusion and every six hours for 48 hours after the infusion, for a total monitoring period of 74 hours. Phlebitis was assessed using the Visual Infusion Phlebitis Scale. This study was prospectively registered on ClinicalTrials.gov (NCT06030141) on November 15, 2023.
RESULTS: Phlebitis was observed in 25% of patients in the sesame oil group, 33.3% in the Nigella sativa oil group, and 80.6% in the control group. A significant difference in phlebitis severity was observed between the groups (p < 0.001), with the highest severity in the control group, the lowest in the sesame oil group, and moderate levels in the Nigella sativa oil group.
CONCLUSION: This study demonstrated that sesame and Nigella Sativa oils were effective in both preventing and reducing the severity of amiodarone-induced phlebitis. The use of sesame oil and Nigella sativa oil in peripheral intravenous catheter care may help reduce amiodarone-induced phlebitis, maintain vascular access integrity, and improve patient comfort. As natural, safe, and cost-effective agents, these oils can be readily incorporated into clinical nursing practice to enhance patient safety and quality of care.