Comparison of Magnesium Sulphate Versus Cold Compress in IV Cannula Induces Phlebitis

October 2, 2023 updated by: Nadia Manzoor, University of Health Sciences Lahore

"Comparison of Magnesium Sulphate Versus Cold Compression on Patients With I.V Cannula Induce Phlebitis Admitted in Lahore General Hospital Lahore a Randomized Control Trial

The use of intravenous (IV) devices is an integral part of patient care in hospitals, clinics, maternity home etc. approximately 80% of hospitalized patients receive I.V therapies. Phlebitis is a complication that is frequently associated with intravenous therapy. Phlebitis is the inflammation of a vein. It most commonly occurs in superficial veins. It is characterized by local pain, tenderness, swelling, induration, and erythema of the venous tract, and a palpable cord-like vein on the infusion site. The most common causes of phlebitis may be mechanical, chemical, and bacterial. Phlebitis may lead to life-threatening complications such as pain, Cellulitis, gangrene and it leads to amputation of the limb. The possibility of clot formation in the veins can lead to serious complications such as deep vein pulmonary embolism, which can cause sudden death. Other complications include septic shock, thrombophlebitis requiring supportive treatment, metastatic infection, the formation of liver abscesses, and endocarditis due to septic emboli. Patients with chronic diseases like diabetes, coronary heart disease, renal failure, hepatic encephalopathy, neurological conditions, and those who are bedridden for extended periods, as well as newborns, face difficulties in maintaining intravenous (IV) cannulas. As a result, needs to maintain central lines for fluids and medication, which is another source of infection. These complications can lead to prolonged hospital stays, increased medical costs, reduced patient satisfaction, and a lower quality of life for the affected individuals. Here the question arises for nurses to check the effectiveness of magnesium sulphate versus cold compress. To find the answer to this question this study will be conducted with the objective of comparing magnesium sulfate versus cold compression on patients with a peripheral intravenous cannula (PIVC) induced phlebitis, hospital-based comparative study and the simple random sampling technique will be used to collect a sample of sixty participants and will be equally distributed into two groups. The study will be conducted in Lahore general hospital Lahore Punjab Pakistan.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Materials & Methods/Subjects & Methods:

Study Design:

• This study will be a Randomized Control Trial.

Setting:

This study will be carried out at the Institute of Nursing University of Health Sciences, Lahore in the collaboration with Lahore General Hospitals Lahore, Pakistan which is one of the major teaching hospitals and sample will be collected from Medical units, surgical units.

Duration:

The anticipated duration of this study will be 12 months.

Sample Size:

The sample size for each group is 35 calculated by using the following formula with estimated 80% power of the study, 95% confidence interval, and assuming that of phlebitis in group1: 96.70% and group 2 is 76.7% (Hongmei et al., 2020) (Sample size is calculated through the WHO online calculator)

Sampling Technique:

A total of 70 patients will be selected by simple random sampling. The patients will be randomized into two groups by lottery method. Group 1 (magnesium sulfate application) and Group 2 (cold compression) will be given. In this method, 70 cards having the same appearance will be used, 35 of them with letter 1 for group 1 and other letter 2 for group 2. Each participant should take one card from this box. Therefore random allocation of subjects will be determined (Dahal et al., 2020).

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The patient admitted for 72 hours or more than 72 hours.

  • Patient with intravenous therapy.
  • Patients with signs of phlebitis 2-4 score on the VIP scale.
  • Age group of 18-50 years and able to report pain.

Exclusion Criteria:

  • Patient with superficial thrombophlebitis and having skin disorder.
  • Patient having associated muscular disorders like DVT, varicose veins,s, etc.
  • Patient with disturbed coagulation profile.
  • I.V Drug abusers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesuuim Sulphate
After the initial assessment, the cannula will be removed from the site (if present) the cannulation site will be cleaned with normal saline. A mixture of 100mg magnesium sulfate and glycerin will be applied to a gauze pad (2" × 2"). This gauze pad placed on the site of phlebitis induced by peripheral intravenous catheter (PIVC). This will be done three times a day for three consecutive days
Other: comparison of magnesium sulphate versus cold compression
This study will involve a total of 70 participants who will be divided into two groups. One group will receive magnesium sulphate, while the other group will receive cold compression. The severity of phlebitis will be assessed in both groups using a visual phlebitis (VIP) rating scale.
Other Names:
  • cold comprssion
Experimental: Cold compression
After the initial assessment, the cannula will be removed from the site (if present) and the area will be cleaned with normal saline. A gauze pad (2" × 2") soaked in cold water with a temperature below 15 °C will be applied to the phlebitis site for 20 minutes. This will be done three times a day for three consecutive days. The cold water will be stored in the refrigerator in the respective wards one day prior to the dressing. It will be taken from the refrigerator just before the dressing and applied within one minute. After 20 minutes of application, the gauze pad for cold compress will be removed from the phlebitis site. From 1st to 3rd Day daily assessment done through VIP scale, will be conducted in both Group A (magnesium sulphate group) and Group B (cold compression group)
Other: comparison of magnesium sulphate versus cold compression
This study will involve a total of 70 participants who will be divided into two groups. One group will receive magnesium sulphate, while the other group will receive cold compression. The severity of phlebitis will be assessed in both groups using a visual phlebitis (VIP) rating scale.
Other Names:
  • cold comprssion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of phlebitis score
Time Frame: 3 days 3 time a day
magnesium sulphate and cold compression reduce the phlebitis score
3 days 3 time a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cold compression 1507

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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