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Necessity of Aspiration in the Ventrogluteal Site

Investigation of the Necessity of Aspiration During The Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421599
Enrollment
834
Registered
2020-06-09
Start date
2019-01-14
Completion date
2020-06-20
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Site, Nursing

Keywords

Ventrogluteal area, aspiration

Brief summary

H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region. H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region. H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain.

Interventions

OTHERThe Necessity of Aspiration

The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same Intramuscular Injection Application Protocol was applied while all the injections were administered.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Patient who came to the Emergency Service Care Unit for Diclofenac Sodium injection * Have no vision and hearing problems, * Who have no disease that may affect their perception of pain * Who can evaluate the Visual Analog Scale correctly, scoring 5 points or less from the VAS, * Body Mass Index is between 18.5-24.9 kg / m2, * Who do not have any discomfort in the extremities that will prevent them from taking the desired position, * No complications due to intramuscular injections such as abscess, infection, tissue necrosis and hematoma in the ventrogluteal region * No nodules or masses in the area

Exclusion criteria

* Patients who refuse the injection are excluded.

Design outcomes

Primary

MeasureTime frameDescription
Individual Introductory Information Form15 minutesThe content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the Individual Introductory Information Form of the patients. Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.
Visual Analog Scale (VAS)5 minutesIntramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to. A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026