Not applicable (healthy adult)
Conditions
Interventions
Trial 1
Group A : Venipuncture using a 24G indwelling needle after 30 minutes of penless tape application.
Group B : Venipuncture using a 22G indwelling needle after 30 minutes of penless tape applica
Sponsors
Goto Takashi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy individuals (equivalent to ASA-PS class 1,2) 2) Sex: male 3) Age: between 18 and 45 years old 4) Those who voluntarily provided written informed consent upon receiving sufficient explanation and understanding the content of the study
Exclusion criteria
Exclusion criteria: 1) Persons with a history of drug allergies. 2) Persons with a history of contact dermatitis in response to topical medication. 3) Persons with or a history of severe liver disease, kidney disease, circulatory disease. 4) Persons whose veins are difficult to identify on the dorsum of the hand, forearm, elbow fossa, or upper arm. 5) Subjects with skin abnormalities (eczema, dermatitis, scars, etc.) that may affect observation of the study drug application site. 6) Persons with Methemoglobinemia. 7) Persons with sensory paralysis in the limbs. 8) Persons who plan to use all drugs except the study drug form the day before the test drug is applied until the end of efficacy evalution. 9) Persons who have already participated in a study of the study drug and have been administered this study drug. 10) Persons who have participated in other research and received the study drug within 120 days of application of the study drug. 11) In addition, persons who are judged by the research-responsible doctor to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Pain assessment using a visual analogue scale 2) Pain assessment using a verbal rating score 3) Pain assessment using current perception threshold | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Pulse rate 2) Blood pressure 3) SpO2 4) ECG Waveform 5) Frequency, rate and severity of adverse events | — |
Contacts
Public ContactKako Sugihara
Asahi University School of Dentistry
Outcome results
None listed