Necessity of Aspiration in the Ventrogluteal Site

Nursing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04421599
• Other study ID #: 0000-0001-7881-8556
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: June 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 834
• Est. completion date: June 20, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injection Site
• Nursing

Intervention

Other:
• The 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.

Locations

Country	Name	City	State
Turkey	Ege University Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Beyea SC, Nicoll LH. Administration of medications via the intramuscular route: an integrative review of the literature and research-based protocol for the procedure. Appl Nurs Res. 1995 Feb;8(1):23-33. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual Introductory Information Form	The 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.	15 minutes
Primary	Visual Analog Scale (VAS)	Intramuscular 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.	5 minutes