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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01955993
Eligibility Criteria:
Inclusion Criteria:
* 1\. The subject will be an inpatient or outpatient admitted for at least 24 hours observation as part of the surgical plan of care
2\. The BMI will be calculated using height and weight and will include the 5th to 84th percentile for the control group and greater than or equal to 95th percentile for the obese adolescents.
3\. All racial and ethnic groups will be included.
Exclusion Criteria:
1. Any patient that is pregnant or lactating.
2. Prior exposure to any opioid including fentanyl within a 24 hour period.
3. Patients with known hypersensitivity to any opioids.
4. History of central nervous system dysfunction and active upper airway disease and liver and renal disease. Patients diagnosed with renal or liver disease as evidenced by abnormal function tests within the past 12 months will be excluded.
5. Patients who are treated with drugs known to affect the cytochrome P450 3A (CYP3A4), like antiepileptics, imidazole derivates, macrolides, corticosteroids and grapefruit juice
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
20 Years
Study:
NCT01955993
Study Brief:
Protocol Section:
NCT01955993