NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052200149

Registered date:09/03/2021

The effect and safety of cooling pack TAK-01 on pain relief for infant during subcutaneous injection

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedvaccine
Date of first enrollment26/05/2021
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)The vaccinated children will be assigned to two groups, a cooled group and a non-cooled group using the test device TAK-01. Apply the test equipment assigned immediately before vaccination to the vaccination site, inoculate within 1 minute after removing it, and judge the pain scale by video.

Outcome(s)

Primary OutcomeFLACC scale evaluation after vaccination by FLACC scale evaluation committee
Secondary OutcomeFLACC scale evaluation after vaccination by an attendant Occurrence of adverse events

Key inclusion & exclusion criteria

Age minimum>= 3age old
Age maximum<= 6age old
GenderBoth
Include criteria(1) Preschoolers aged 3 to 6 at the time of case registration (2) Those who are vaccinated with Japanese encephalitis vaccine or influenza vaccine by subcutaneous injection at the time of case registration (3) Those who have obtained the voluntary written consent of the substitute for participation in this study.
Exclude criteria(1) Those who are crying harder than before obtaining consent (2) Persons with hypoesthesia or intellectual disability at the time of obtaining consent (3)Those who are scheduled to be vaccinated with two or more types on the date of consent acquisition (4)Those who used analgesic within 6 hours before case registration (5)Those who have been diagnosed or suspected of having a cold stimulus-related disease such as Raynaud's syndrome or sickle cell disease at the time of obtaining consent (6) Those who are judged by the research responsible (sharing) doctor to be inappropriate for participation in this research

Related Information

Contact

Public contact
Name Utako Shirono
Address 2-1-1 Minatojima minamimachi,Chuo-ku,Kobe City,Hyogo Hyogo Japan 650-0047
Telephone +81-78-302-4321
E-mail ushirono@kcho.jp
Affiliation Kobe City Medical Center General Hospital
Scientific contact
Name Ikuo Okafuji
Address 2-1-1 Minatojima minamimachi,Chuo-ku,Kobe City,Hyogo Hyogo Japan 650-0047
Telephone +81-78-302-4321
E-mail ikuoka@gmail.com
Affiliation Kobe City Medical Center General Hospital