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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT07287735
Eligibility Criteria:
Inclusion Criteria:
* • Age 12 to \<18 years
* Weight ≥10th percentile; BMI ≥5th percentile
* Oxygen saturation ≥98%
* Undergoing nasal diagnostic procedure or surgery
* Able to assent; parent/guardian able to provide consent
* Use of acceptable contraception (if applicable)
Exclusion Criteria:
* History of seizure
* Hypersensitivity to cocaine or ester anesthetics
* Recent intranasal cocaine use
* Positive drug screen
* Use of prohibited medications (SSRIs, MAOIs, decongestants, stimulants, etc.)
* Cardiovascular disease, abnormal ECG
* Hepatic or renal disease
* Nasal mucosa trauma preventing pledget placement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07287735
Study Brief:
Protocol Section:
NCT07287735