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

NCT ID: NCT04859738

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-04
• Study Completion Date: 2020-10-20

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.

Conditions

Peripheral Intravenous Catheterization Application

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experiment I Group (Lidocaine Spray)

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

Group Type: EXPERIMENTAL

Lidocaine Spray

Intervention Type: DRUG

Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.

Lidocaine Spray was applied 60 seconds before to the area where the peripheral intravenous catheter application of the patients in the Experiment I Group (Lidocaine Spray) will be performed. After waiting 60 seconds, peripheral intravenous catheter application was performed.

The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.

After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse.

Experiment II Group (Benzokain Sprey)

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

Group Type: EXPERIMENTAL

Benzokain Sprey

Intervention Type: DRUG

Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.

Benzocaine Spray was applied 60 seconds before to the area where the peripheral intravenous catheter will be applied to the patients in the Experiment II Group (Benzocaine Spray). After waiting 60 seconds, peripheral intravenous catheter application was performed.

The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.

After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse.

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Alcohol

Intervention Type: OTHER

Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.

In patients in the placebo group, alcohol was sprayed 60 seconds before the area where the peripheral intravenous catheter will be applied. After waiting 60 seconds, peripheral intravenous catheter application was performed.

The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.

After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse.

Interventions

Lidocaine Spray

Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.

Lidocaine Spray was applied 60 seconds before to the area where the peripheral intravenous catheter application of the patients in the Experiment I Group (Lidocaine Spray) will be performed. After waiting 60 seconds, peripheral intravenous catheter application was performed.

The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.

After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse.

Intervention Type: DRUG

Benzokain Sprey

Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.

Benzocaine Spray was applied 60 seconds before to the area where the peripheral intravenous catheter will be applied to the patients in the Experiment II Group (Benzocaine Spray). After waiting 60 seconds, peripheral intravenous catheter application was performed.

The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.

After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse.

Intervention Type: DRUG

Alcohol

Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.

In patients in the placebo group, alcohol was sprayed 60 seconds before the area where the peripheral intravenous catheter will be applied. After waiting 60 seconds, peripheral intravenous catheter application was performed.

The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.

After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Ali Kaplan

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes University

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ali KAPLAN Erciyes University

Identifier Type: -

Identifier Source: org_study_id