The Effect of Lidocaine and Benzocaine on Pain and Injection Satisfaction in Peripheral Intravenous Catheter Application

TC Erciyes University

Status and phase: Completed; Phase 3

Conditions: Peripheral Intravenous Catheterization Application

Treatments: Drug: Benzokain Sprey; Drug: Lidocaine Spray; Other: Alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT04859738

Ali KAPLAN Erciyes University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Experiment I Group (Lidocaine Spray)

Experimental group

Description:

Lidocaine Spray was applied to Experiment I group before peripheral intravenous catheter application.

Treatment:

Drug: Lidocaine Spray

Experiment II Group (Benzokain Sprey)

Experimental group

Description:

Benzokain Sprey was applied to Experiment II group before peripheral intravenous catheter application.

Treatment:

Drug: Benzokain Sprey

Placebo Group

Placebo Comparator group

Description:

Alcohol was administered to the placebo group prior to peripheral intravenous catheter application.

Treatment:

Other: Alcohol