NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1041240045

Registered date:13/06/2024

Analgesic effect of lidocaine/propitocaine eutectic mixture patch

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNot applicable (healthy adult)
Date of first enrollment13/06/2024
Target sample size190
Countries of recruitment
Study typeInterventional
Intervention(s)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 application. Group C : Venipuncture with 24G indwelling needle after 60 minutes of application of EMLA patch. Group D : Venipuncture with 22G indwelling needle after 60 minutes of application of EMLA patch. Trial 2 Group A : Venipuncture with 24G indwelling needle after 60 minutes of application of EMLA patch. Group B : Venipuncture with 22G indwelling needle after 60 minutes of application of EMLA patch. Group C : Venipuncture with 24G indwelling needle after 90 minutes of application of EMLA patch. Group D : Venipuncture with 22G indwelling needle after 90 minutes of application of EMLA patch. Group E : Venipuncture with 24G indwelling needle after 120 minutes of application of EMLA patch. Group F : Venipuncture with 22G indwelling needle after 120 minutes of application of EMLA patch.

Outcome(s)

Primary Outcome1) Pain assessment using a visual analogue scale 2) Pain assessment using a verbal rating score 3) Pain assessment using current perception threshold
Secondary Outcome1) Pulse rate 2) Blood pressure 3) SpO2 4) ECG Waveform 5) Frequency, rate and severity of adverse events

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 45age old
GenderMale
Include criteria1) 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
Exclude criteria1) 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.

Related Information

Contact

Public contact
Name Kako Sugihara
Address 1851-1, Hozumi, Mizuho-shi, Gifu Gifu Japan 501-0296
Telephone +81-58-329-1479
E-mail sugik2@dent.asahi-u.ac.jp
Affiliation Asahi University School of Dentistry
Scientific contact
Name Takashi Goto
Address 1851-1, Hozumi, Mizuho-shi, Gifu Gifu Japan 501-0296
Telephone +81-58-329-1479
E-mail takashigoto@dent.asahi-u.ac.jp
Affiliation Asahi University Medical and Dental Center