The Effectiveness of Topical Sesame Oil in Preventing Phlebitis at IV Cannula Sites in Adults
Condition: Phlebitis; Thrombophlebitis
MeSH terms: Phlebitis; Thrombophlebitis
Study type: Interventional

Summary: 
      The goal of this randomised controlled trial is to determine the effectiveness of topical
      sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult
      patients within a cardiovascular and cardiothoracic department of a tertiary hospital.

      The main question it aims to answer is:

      Is topical sesame oil effective in preventing phlebitis at peripheral IV cannula sites in
      adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital?

      Participants will be randomly allocated to the experimental or control group with the use of
      a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame
      oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12
      hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along
      the vein, with a width of 2cm on either side.

      Researchers will compare the phlebitis incidence and severity of each group to see if topical
      sesame oil is more effective than liquid paraffin oil in preventing phlebitis at IV cannula
      sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary
      hospital.
    

Detailed description: 
      The goal of this randomised controlled trial is to determine the effectiveness of topical
      sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult
      patients within a cardiovascular and cardiothoracic department of a tertiary hospital.

      All newly admitted patients with an existing IV cannula will be approached after being
      admitted into an inpatient ward. This will take place within 12 hours of the IV cannula
      insertion. They will not be approached if in distress, drowsy or immediately prior to a
      surgical procedure. The IV cannula will be tested for patency, and assessed for redness,
      swelling, pain, a palpable venous cord or pyrexia. If any of these symptoms are present, or
      if the IV cannula is not patent, the recruitment will be terminated.

      Participants will be randomly allocated to the experimental or control group with the use of
      a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame
      oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12
      hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along
      the vein, with a width of 2cm on either side.

      Demographic and clinical data will be recorded into a table. The patient will be instructed
      not to wash or wipe the topical agent off. The time and date of the start of treatment
      applied and subsequent treatments at 12 hour intervals will be documented. At the start of
      the study and at each 12 hour interval, the investigator will observe for signs of phlebitis
      using the modified Visual Infusion Phlebitis (VIP) scoring tool (1), before application of
      the next treatment. The study investigators will be the only ones applying the
      treatment/control and completing the data collection form every 12 hours.

      Application of the treatment or control will be made every 12 hours for up to 72 hours, where
      the IV cannula will then be removed according to hospital guidelines. The IV cannula site
      will be observed, every 12 hours for up to 24 hours post IV cannula removal, for phlebitis or
      complications.

      Patients will be withdrawn from the study the moment they show signs of adverse reactions
      from the topical treatment or control.

      Participants will be involved in the study for a maximum of 96 hours. If the IV cannula is
      removed accidentally or not due to phlebitis before the 72-hour period is up, re-insertion of
      a new cannula and re-application of oils will not be done on a new site.

      The application of either sesame oil or liquid paraffin oil is not part of the routine
      procedures or standard of care in the ward, and will only be applied for the purpose of this
      research. Both the sesame oil and liquid paraffin oil are marketed products and will be used
      as per label.

      All hardcopy research data will be stored in in a locked cupboard with lock and key access
      within the National Heart Centre, Singapore. All soft copies will be stored in a password
      protected Laptop belonging to the principal investigator. Only the principal investigator
      will have access to the research data. All other members of the research team will access the
      data through the principal investigator. The physical research data will be kept under lock
      and key for 7 years after the completion of the research study or date of publication of the
      research using the research data, whichever is later. After which, all data will be
      destroyed. Hardcopies will be shredded and soft copies will be deleted.

      Subjects may withdraw voluntarily from participation in the study at any time. Subjects may
      also withdraw voluntarily from receiving the study intervention for any reason. Upon
      withdrawal, IV cannula sites will continue to be observed for 24 hours at 12-hour intervals
      for potential reactions to the oils or signs of phlebitis. If there are any adverse reactions
      to the oils or signs of phlebitis during the 24-hour observation period, the patient will be
      referred to the attending physician and medical treatment will be rendered. The patient will
      continue to receive follow-up and medical treatment until symptoms have resolved.

      The study may be discontinued at any time, if safety issues arise. If the risks to
      participants unexpectedly outweigh the benefits due to unexpected severe adverse events due
      to the application of the treatment or control oils, the study may then be suspended until
      the risk-benefit ratio is re-evaluated.
    

Intervention name(s): Topical Sesame Oil; Liquid paraffin oil
Intervention type(s): Other; Other
Intervention description(s): 5 drops/0.25mls of sesame oil applied to the IV cannula site at 12 hourly intervals for 72 hours; 5 drops/0.25mls of liquid paraffin oil applied to the IV cannula site at 12 hourly intervals for 72 hours
Intervention MeSH terms: Mineral Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intravenous cannula; IV cannula; Adult; Cardiovascular; Cardiothoracic; Phlebitis; Thrombophlebitis