The Effectiveness of Topical Sesame Oil in Preventing Phlebitis at IV Cannula Sites in Adults

A Randomised-controlled Trial on the Effectiveness of Topical Sesame Oil in Preventing Phlebitis at Intravenous Cannula Sites in Adult Patients

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.

Study Overview

• Status: Completed
• Conditions: Phlebitis; Thrombophlebitis
• Intervention / Treatment: Other: Topical Sesame Oil; Other: Liquid paraffin oil

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.

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 5 drops/0.25mls of 100% sesame oil will be applied to the IV cannula site, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side, every 12 hours for 72 hours.	Other: Topical Sesame Oil; 5 drops/0.25mls of sesame oil applied to the IV cannula site at 12 hourly intervals for 72 hours
Placebo Comparator: Control; 5 drops/0.25mls of liquid paraffin oil will be applied to the IV cannula site, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side, every 12 hours for 72 hours.	Other: Liquid paraffin oil; 5 drops/0.25mls of liquid paraffin oil applied to the IV cannula site at 12 hourly intervals for 72 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phlebitis incidence	Measuring the incidence of phlebitis across both the intervention and control groups	At 12 hourly intervals for a total of 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phlebitis severity	Documenting the severity of phlebitis using the Visual Infusion Phlebitis (VIP) scoring tool, across both the intervention and control groups. It is rated on a scale of zero to five, with five being the worst possible outcome.	At 12 hourly intervals for a total of 72 hours

Collaborators and Investigators

• Sponsor: National Heart Centre Singapore
• Investigators: Principal Investigator: Jasmine Tan, Nanyang Polytechnic

Publications and helpful links

General Publications

• Jackson A. Infection control--a battle in vein: infusion phlebitis. Nurs Times. 1998 Jan 28-Feb 3;94(4):68, 71. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): October 21, 2022

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adult; Cardiovascular; Thrombophlebitis; Phlebitis; intravenous cannula; IV cannula; Cardiothoracic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Phlebitis; Thrombophlebitis; Dermatologic Agents; Emollients; Mineral Oil
• Other Study ID Numbers: 2021/2804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No