Fentanyl Metabolism in Obese Adolescents

Completed

Conditions studied: Morbid Obesity

In brief

Fentanyl is a frequently used pain medication in pediatric and adult anesthesia. Although there are some studies considering the breakdown of oral, transmucosal and intravenous fentanyl preparations in children, the disposition of fentanyl in pediatric patients has not been sufficiently described. This study aims to show that the clearance of fentanyl in obese children and adolescents is increased as compared to children with a normal weight. Consequently, the elimination half-life of fentanyl is different in overweight and obese children from that in children having a normal body weight.

Key facts

Study ID

NCT01955993

Run by

Children's National Research Institute

People needed

12

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2013-10-08

Who can join

Age: 12 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1. The subject will be an inpatient or outpatient admitted for at least 24 hours observation as part of the surgical plan of care
• 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.
• All racial and ethnic groups will be included.

You may not qualify if…

• Any patient that is pregnant or lactating.
• Prior exposure to any opioid including fentanyl within a 24 hour period.
• Patients with known hypersensitivity to any opioids.
• 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.
• Patients who are treated with drugs known to affect the cytochrome P450 3A (CYP3A4), like antiepileptics, imidazole derivates, macrolides, corticosteroids and grapefruit juice

Where it is running

• Childrens National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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