NCT04859738

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.
OTHER	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.

Timeline

• Start date: 2020-03-04
• Primary completion: 2020-07-07
• Completion: 2020-10-20
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: Turkey (Türkiye)