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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT00747669
Eligibility Criteria:
Inclusion Criteria:
* Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
* Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
* Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
* The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.
Exclusion Criteria:
* Subject has known allergies or sensitivities to any component of Synera.
* Subject has clinically significant laboratory abnormalities.
* Subject has known multiple allergies that could indicate hypersensitive skin.
* Subject has known active atopic dermatitis at or near the patch application site.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Months
Study:
NCT00747669
Study Brief:
Protocol Section:
NCT00747669