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Comparison of Two Methods of Immunization for Intramuscular Injections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01721083
First received: November 1, 2012
Last updated: July 15, 2014
Last verified: July 2014

November 1, 2012
July 15, 2014
October 2012
July 2014   (final data collection date for primary outcome measure)
Perceived pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Subjects will be asked to rate perceived pain on scale of 0-10
Same as current
Complete list of historical versions of study NCT01721083 on ClinicalTrials.gov Archive Site
  • Medication leakage [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Any medication leakage from either arm within 72 hours
  • Redness at injection site [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.
Same as current
Not Provided
Not Provided
 
Comparison of Two Methods of Immunization for Intramuscular Injections
Comparison of Two Methods of Immunization for Intramuscular Injections

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Consequences of Immunization Method
  • Procedure: Procedure: Z-track
    Subject received immunization by z-track
  • Procedure: Procedure: Bunch
    Subject receives immunization by bunch method.
  • Experimental: Z-Track immunization
    Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
    Intervention: Procedure: Procedure: Z-track
  • Active Comparator: Bunch immunization
    Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
    Intervention: Procedure: Procedure: Bunch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy adults without latex allergy over 18 years of age

Exclusion Criteria:

  • latex allergy
  • illness
  • 18 years or less
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01721083
DDD# 602056
No
Christiana Care Health Services
Christiana Care Health Services
Not Provided
Principal Investigator: Lynn E Bayne, PhD, ARNP, NNP-BC Christiana Care Health Services
Christiana Care Health Services
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP