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Effect of sesame oil and Nigella sativa oil on the prevention of amiodarone-induced phlebitis: a randomized controlled trial.

  • 2026-03-18
  • Explore (New York, N.Y.) 22(3)
    • Burcu Nal
    • Dilek Sari
    • Mehmet Ali Astarcioğlu
    • İsmail Şen

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 108
Population
108 patients who received amiodarone infusion in the coronary intensive care unit between November 2023 and August 2024
Methods
randomized controlled trial with three parallel groups; three-arm, block-randomized controlled trial; sesame oil (n=36), Nigella sativa oil (n=36), or control (n=36); five drops of oil applied topically to 10-cm area around catheter site once before infusion and every 6 hours thereafter; control group received no intervention
Blinding
Open-label
Duration
26-hour infusion plus 48 hours post-infusion monitoring, total 74 hours
Funding
Unclear
  • Large Human Trial

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.

Research Insights

  • Black Cumin→Reduced Phlebitis Incidence

    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.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    five drops topically to a 10-cm area around the catheter site every 6 hours
  • Black Cumin→Reduced Phlebitis Severity

    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.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    five drops topically to a 10-cm area around the catheter site every 6 hours
  • Sesame→Reduced Phlebitis Incidence

    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.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    five drops topically to a 10-cm area around the catheter site every 6 hours
  • Sesame→Reduced Phlebitis Severity

    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.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    five drops topically to a 10-cm area around the catheter site every 6 hours
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