Comparison of Two Methods of Immunization for Intramuscular Injections

Christiana Care Health Services

Status and phase: Completed; Phase 4

Conditions: Consequences of Immunization Method

Treatments: Procedure: Procedure: Z-track; Procedure: Procedure: Bunch

Study type: Interventional

Funder types: Other

Identifiers

NCT01721083

DDD# 602056

Details and patient eligibility

About

This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Full description

This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adults without latex allergy over 18 years of age

Exclusion criteria

• latex allergy
• illness
• 18 years or less

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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511 participants in 2 patient groups

Z-Track immunization

Experimental group

Description:

Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

Treatment:

Procedure: Procedure: Z-track

Bunch immunization

Active Comparator group

Description:

Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

Treatment:

Procedure: Procedure: Bunch