Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT01394250
Eligibility Criteria:
Inclusion Criteria:
* Subject is aged 4 to 18 years of age
* Subjects will be having a peripheral IV line placed at the discretion of the treating physician for usual care of presenting complaints.
* Physician in charge of the subject is willing to wait the 30 minutes needed for the study preparation
* Subject/caregiver understands English
* Parent or legal guardian has signed Institutional Review Board (IRB) approved informed consent and subject (if age 7 years or older) has given assent
Exclusion Criteria:
* Subject is critically ill with a triage category of 1
* Subject has a condition that precludes the use of the self-report pain scale
* Subject has an abrasion, infection or break in skin in the area where Buzzy® would be placed
* Nerve damage is present in the extremity for planned IV placement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT01394250
Study Brief:
Protocol Section:
NCT01394250