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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052200149
Enrollment
60
Registered
2021-03-09
Start date
2021-05-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vaccine

Interventions

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 vacc

Sponsors

Okafuji Ikuo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
FLACC scale evaluation after vaccination by FLACC scale evaluation committee

Secondary

MeasureTime frame
FLACC scale evaluation after vaccination by an attendant Occurrence of adverse events

Contacts

Public ContactUtako Shirono

Kobe City Medical Center General Hospital

ushirono@kcho.jp+81-78-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026