Ice Application for Oxacillin-Related Phlebitis and Pain

NCT07820956 | Completed

• 2 other identifiers: FYH-IRB-111004111004
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated whether ice application could reduce pain and peripheral intravenous phlebitis associated with oxacillin administration. Hospitalized patients receiving intravenous oxacillin were assigned to either an ice application group or a control group. In the intervention group, ice was applied to the area around the peripheral intravenous catheter before oxacillin administration. In the control group, a room-temperature water bag was applied in the same manner. Pain after oxacillin administration and signs of phlebitis at the intravenous catheter site were assessed and compared between the two groups. The study aimed to determine whether ice application could provide a simple, non-pharmacological approach to reducing oxacillin-related pain and phlebitis.

Conditions

Peripheral Intravenous Phlebitis; Injection Site Pain; Pain

Keywords

Oxacillin; Ice Application; Peripheral Intravenous Catheter; Phlebitis; Pain; Cryotherapy

Outcome Measures

Primary Outcomes (2)

• Pain Intensity After Intravenous Oxacillin Administration

  Pain intensity associated with intravenous oxacillin administration was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period. Higher pain scores indicated greater pain intensity.

  Up to 72 hours after intravenous oxacillin administration

• Pain Intensity After Intravenous Oxacillin Administration

  Pain intensity associated with intravenous oxacillin administration was assessed using a numerical rating scale, with higher scores indicating greater pain. Pain was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period.

  From 1 to 72 hours after initiation of the study intervention, assessed at 1-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, and 65-72 hours.

Study Arms (2)

Ice Application Group

EXPERIMENTAL

Participants assigned to this group received ice application around the peripheral intravenous catheter site before intravenous oxacillin administration.

Other: Ice Application

Room-Temperature Water-Bag Control Group

ACTIVE COMPARATOR

Participants assigned to this group received a room-temperature water-bag application around the peripheral intravenous catheter site before intravenous oxacillin administration.

Other: Room-Temperature Water-Bag Application

Interventions

Ice Application OTHER

Ice was applied around the peripheral intravenous catheter site before intravenous oxacillin administration. The intervention was intended to reduce pain associated with oxacillin administration and the occurrence of peripheral intravenous phlebitis.

Ice Application Group

Room-Temperature Water-Bag Application OTHER

A room-temperature water bag was applied around the peripheral intravenous catheter site before intravenous oxacillin administration as the control condition.

Room-Temperature Water-Bag Control Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 20 to 60 years. Conscious and able to participate in the study. Intravenous injection site located on either hand. Receiving a single antibiotic medication during the study. Eligible regardless of sex or medical diagnosis.

You may not qualify if:

• Dementia. Psychiatric disorders. Skin rash at the study site. Purpura. Pregnancy. Current oral corticosteroid use. Hemodialysis. Administration of a second medication or an injection containing two or more medications during the study.

Sponsors & Collaborators

• Central Taiwan University of Science and Technology: lead

Study Sites (1)

Feng Yuan Hospital, Ministry of Health and Welfare

Fengyuan, Taiwan

Location

MeSH Terms

Conditions

Pain; Phlebitis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: April 7, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)