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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT01740193
Eligibility Criteria:
Inclusion Criteria:
* The subject is male or female;
* The subject is of any racial and ethnic groups;
* The subject is age 12 months to 10 years (inclusive);
* The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
* The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
* The subject is American Society of Anesthesiologists (ASA) patient classification I-II
* The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Exclusion Criteria:
* Additional surgical procedures are being performed concurrently;
* The subject is ASA classification \> II;
* The subject has pre-existing allergies to local anesthetics;
* The subject receives midazolam as a premedication;
* The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
* The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
10 Years
Study:
NCT01740193
Study Brief:
Protocol Section:
NCT01740193