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

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.

Study Overview

• Status: Unknown
• Conditions: Injection Site; Nursing
• Intervention / Treatment: Other: The Necessity of Aspiration

• Study Type: Interventional
• Enrollment (Actual): 834
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group A; Experimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds.	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.
No Intervention: Control Group; Control Group who were administered intramuscular injection during which aspiration lasted for 1-2 seconds.
Experimental: Experimental Group B; Experimental Group B who were not administered aspiration during IM injection.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ege University

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0897-1897(95)80279-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Anticipated): June 10, 2020
• Study Completion (Anticipated): June 20, 2020

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: aspiration; Ventrogluteal area
• Other Study ID Numbers: 0000-0001-7881-8556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No