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

NCT06216522 | Completed DMC

• 1 other identifier: 2021/2804
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phlebitis; Thrombophlebitis

Keywords

intravenous cannula; IV cannula; Adult; Cardiovascular; Cardiothoracic; Phlebitis; Thrombophlebitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Phlebitis severity

  At 12 hourly intervals for a total of 72 hours

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Topical Sesame Oil OTHER

5 drops/0.25mls of sesame oil applied to the IV cannula site at 12 hourly intervals for 72 hours

Intervention

Liquid paraffin oil OTHER

5 drops/0.25mls of liquid paraffin oil applied to the IV cannula site at 12 hourly intervals for 72 hours

Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Related Publications (1)

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

  PMID: 9510815 BACKGROUND

MeSH Terms

Conditions

Phlebitis; Thrombophlebitis

Interventions

Sesame Oil; Mineral Oil

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Petrolatum; Hydrocarbons; Organic Chemicals

Study Officials

• Jasmine Tan

  Nanyang Polytechnic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: April 12, 2022
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)