Peripheral Intravenous Catheterization ApplicationPhase 3NCT04859738
The Effect of Lidocaine and Benzocaine on Pain and Injection Satisfaction in Peripheral Intravenous Catheter Application
A Phase 3 study testing Lidocaine Spray, Benzokain Sprey and Alcohol in people with Peripheral Intravenous Catheterization Application, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Intravenous Catheterization Application
- What is being tested?
- Lidocaine Spray, Benzokain Sprey and Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2020to 20 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Topical Lidocaine and Benzocaine on Pain and Injection Satisfaction in Peripheral Intravenous Catheter Applications
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.
Read the 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.
- Being tested
- Lidocaine Spray, Benzokain Sprey, Alcohol
- Keywords
- Peripheral intravenous catheterization, pain, injection satisfaction, pharmacological method, lidocaine, benzocaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine SprayDrug
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.
Benzokain SpreyDrug
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.
AlcoholOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experiment I Group (Lidocaine Spray) | Experimental | Lidocaine Spray was applied to Experiment I group before peripheral intravenous catheter application. Receives: Drug: Lidocaine Spray |
| Experiment II Group (Benzokain Sprey) | Experimental | Benzokain Sprey was applied to Experiment II group before peripheral intravenous catheter application. Receives: Drug: Benzokain Sprey |
| Placebo Group | Placebo comparator | Alcohol was administered to the placebo group prior to peripheral intravenous catheter application. Receives: Other: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level (Visual Analog Scale)
Visual Analog Scale is a scale used to measure the severity of pain. It is used to numerically convert the pain value that cannot be measured numerically. The two end definitions of the pain parameter are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line, placing a dot or marking on this line. It is a 100 mm (10 cm) ruler that can be used horizontally and vertically, with painlessness on one end and the most severe pain on the other. "0 mm" means painlessness, "100 mm" means the most severe pain. The individual indicates the severity of the pain he feels on this scale. In line with these data, horizontally prepared Visual Analog Scale was used in this study to determine the severity of pain felt by patients during peripheral IV catheter injection. Pain severity score measurements were evaluated in mm.
Measured: Evaluation was made immediately after application.
Secondary outcomes (1)
Injection Satisfaction Scale
It is a scale created to determine the satisfaction status of patients due to injection after peripheral IV catheter injection. The two tip definitions of the injection satisfaction parameter are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line, point or mark on this line. It is a 100 mm (10 cm) ruler that can be used horizontally and vertically, with one end saying "I'm not satisfied at all, but very satisfied" on the other. "0mm" means not satisfied at all, "100mm" means very satisfied. The individual determines the degree of satisfaction with the injection felt on this scale. In line with the above findings, horizontally prepared Injection Satisfaction Scale was used in this study to determine the injection satisfaction levels of patients due to peripheral intravenous catheter injection application. Injection satisfaction levels score measurements were evaluated in mm.
Measured: Evaluation was made immediately after application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start4 Mar 2020
- Primary completion7 Jul 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous Catheterization ApplicationStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaplan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859738
- Sponsor's protocol ID
- Ali KAPLAN Erciyes University
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Lidocaine and Benzocaine on Pain and Injection Satisfaction in Peripheral Intravenous Catheter Applications
- ClinicalTrials.gov ID
- NCT04859738
- Acronym / sponsor ID
- Ali KAPLAN Erciyes University
- Keywords
- Peripheral intravenous catheterization, pain, injection satisfaction, pharmacological method, lidocaine, benzocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experiment I Group (Lidocaine Spray) | Experimental | Drug: Lidocaine SprayLidocaine Spray was applied to Experiment I group before peripheral intravenous catheter application. |
| Experiment II Group (Benzokain Sprey) | Experimental | Drug: Benzokain SpreyBenzokain Sprey was applied to Experiment II group before peripheral intravenous catheter application. |
| Placebo Group | Placebo comparator | Other: AlcoholAlcohol was administered to the placebo group prior to peripheral intravenous catheter application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine SprayIndividuals 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 | Experiment I Group (Lidocaine Spray) |
| Benzokain SpreyIndividuals 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. | Drug | Experiment II Group (Benzokain Sprey) |
| AlcoholIndividuals 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. | Other | Placebo Group |
Primary outcome
Pain level (Visual Analog Scale)
Time frame: Evaluation was made immediately after application.
Visual Analog Scale is a scale used to measure the severity of pain. It is used to numerically convert the pain value that cannot be measured numerically. The two end definitions of the pain parameter are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line, placing a dot or marking on this line. It is a 100 mm (10 cm) ruler that can be used horizontally and vertically, with painlessness on one end and the most severe pain on the other. "0 mm" means painlessness, "100 mm" means the most severe pain. The individual indicates the severity of the pain he feels on this scale. In line with these data, horizontally prepared Visual Analog Scale was used in this study to determine the severity of pain felt by patients during peripheral IV catheter injection. Pain severity score measurements were evaluated in mm.
1 secondary outcome
Injection Satisfaction Scale
Time frame: Evaluation was made immediately after application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Spray, Benzokain Sprey and Alcohol in people with Peripheral Intravenous Catheterization Application, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (Visual Analog Scale) (time frame: Evaluation was made immediately after application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.