Clinical trial NCT04859738: The Effect of Lidocaine and Benzocaine on Pain and Injection Satisfaction in Peripheral Intravenous Catheter Application
Official title: The Effect of Topical Lidocaine and Benzocaine on Pain and Injection Satisfaction in Peripheral Intravenous Catheter Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Intravenous Catheterization Application
Keywords: Peripheral intravenous catheterization
pain
injection satisfaction
pharmacological method
lidocaine
benzocaine
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: During the data collection, 120 individuals who met the inclusion criteria and were selected with the randomization list created on the computer constituted the sample of the study.
Primary purpose: PREVENTION

Brief summary: Objective: This research was conducted as a randomized controlled, double-blind experimental study to determine the effect of topical lidocaine and benzocaine on patient's pain and injection satisfaction before peripheral intravenous catheter application.

Study Design: The study was completed with 120 individuals who were treated in the green area of a University Hospital Emergency Service and met the inclusion criteria of the study. In collecting research data; Case Report Form (ORF), Baseline Algometer (66 Lb / 30 Kg) and Informed Consent Form were used. Lidocaine Spray, Benzocaine Spray and Alcohol were used in research groups.

Detailed description: Objective: This research was conducted as a randomized controlled, double-blind experimental study to determine the effect of topical lidocaine and benzocaine on patient's pain and injection satisfaction before peripheral intravenous catheter application.

Study Design: The study was completed with 120 individuals who were treated in the green area of a University Hospital Emergency Service and met the inclusion criteria of the study. Ethics committee approval, Turkey Pharmaceuticals and Medical Devices Agency clinical research permission, institutional permission and written informed consent from individuals were obtained in the study. In collecting research data; Case Report Form (ORF), Baseline Algometer (66 Lb / 30 Kg) and Informed Consent Form were used. Lidocaine Spray, Benzocaine Spray and Alcohol were used in research groups. Private health insurance was provided for all patients included in the study for complications arising from the procedure. The data obtained from the research were evaluated in computer environment using IBM SPSS Statistics 23.0 statistics package program.

Eligibility criteria: Inclusion Criteria:

* Can speak and understand Turkish,
* Over the age of 18,
* Under the age of 65,
* Located in the green area of Erciyes University Emergency Service,
* Having orientation in place and time,
* Not using psychiatric medication due to any psychiatric illness,
* Not using central nervous system drugs,
* Does not have any known chronic disease,
* No vision or hearing problems,
* No signs of phlebitis, scar tissue, dermatitis, incision or infection in the area to be operated,
* Does not have pain anywhere on the body that will affect the result of the study and whose visual comparison scale pain score is zero at the time of application
* No experience of IV catheter application in the last month,
* Not taking analgesic in the last 24 hours,
* Intravenous drug treatment is ordered,
* With Baseline Algometer device, the average pressure pain threshold is 8-16 pounds (Lb),
* Individuals who volunteered to participate in the study and signed the written consent form were included in the study.

Exclusion Criteria:

* Not wanting to participate in the study,
* A history of sensitivity to the study drug or related drugs or any drug excipient,
* Having clinically significant vital signs,
* Stating that he / she is addicted to alcohol and drugs,
* Those who were incompetent or unwilling to comply with the study protocol or who stated that they experienced difficulties in the procedures related to the study (eg establishing vascular access before) were not included in the study.
* In patients who developed IV catheter complications (swelling of the vascular access, hematoma) during the study,
* In patients whose IV catheter insertion cannot be performed at the first time,
* The study was terminated in patients who wanted to leave the study anywhere in the study.

Primary outcomes:
measure: Pain level (Visual Analog Scale)
timeFrame: Evaluation was made immediately after application.
Secondary outcomes:
measure: Injection Satisfaction Scale
timeFrame: Evaluation was made immediately after application.
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References: