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:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03653260
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 3-12
* About to undergo venipuncture or peripheral venous cannulation at the back of the hand or antecubital fossa
* Have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES scale (age 3-12) and the extremes of pain on a 100 mm visual analog scale (VAS) (ages 8-12)
* Signed informed consent, cooperative and agree to attend follow-up visits
Exclusion Criteria:
* Any medical condition, non-compliance or instability (including but not limited to exceptionally upset, crying, anxiety) that in the judgement of the investigator might adversely affect the conduct of the study
* Used any (including external or inhaled) sedatives, analgesics, anaesthetics or other agents/device that may affect the efficacy assessment
* Subjects with tattoos, surgical scars, ports, implantable devices or a skin condition (e.g. excessive body hair) that may have interfered with the placement of Zingo or skin site assessments
* Active local infection or other skin pathology at the site of venipuncture or peripheral venous cannulation.
* Venipuncture of peripheral venous cannulation at the proposed site within the prior two weeks (longer if the wound is apparent)
* Previous history of allergic reactions to any local anaesthetic or tape/adhesive dressing.
* Participated in a clinical trial within three months prior to administration of study drug, or have already enrolled in a Zingo clinical trial before
* At the discretion of the investigator, any subjects that may have to be withdrawn from the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT03653260
Study Brief:
Protocol Section:
NCT03653260