The Effectiveness of Topical Sesame Oil in Preventing Phlebitis at IV Cannula Sites in Adults (NCT06216522) | Clinical Trial Compass
CompletedNot Applicable
The Effectiveness of Topical Sesame Oil in Preventing Phlebitis at IV Cannula Sites in Adults
Singapore263 participantsStarted 2022-04-12
Plain-language 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.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 21-80
* Patients must speak and understand either English or Mandarin
* Patients who possess a peripheral IV cannula
* IV cannula must have been inserted for less than 12 hours
* IV cannula must be on an upper extremity
* IV cannula must be patent
* IV cannula sites must show no signs of redness, swelling, pain, a palpable venous cord or pyrexia
* Patient must be admitted to a cardiology ward in the National Heart Centre Singapore
Exclusion Criteria:
* Patients who do not speak or understand either English or Mandarin
* Patients with venous insufficiency
* Patients with coagulopathies
* Patients with cognitive or sensory impairments that would inhibit their ability to rate their pain via a Numerical Rating Scale (NRS)
* Patients who are receiving medications that might interfere with timely reporting of adverse events (eg. medications that cause severe drowsiness)
* Patients who report allergies to sesame or liquid paraffin oil
* IV cannulas that were inserted and used for resuscitation
* Patients with existing skin conditions that cause their skin to be red or swollen and might affect the investigators ability to assess for phlebitis
* Patients who possess more than one peripheral IV cannula will only be included in the study once. All subsequent IV cannula insertions will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phlebitis incidence
Timeframe: At 12 hourly intervals for a total of 72 hours