Fentanyl Metabolism in Obese Adolescents

NCT01955993 | Completed

• 1 other identifier: 1809
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morbid Obesity

Keywords

Obesity, adolescence,pharmacokinetics,fentanyl

Outcome Measures

Primary Outcomes (1)

• Systemic clearance of fentanyl and its metabolites norfentanyl, hydroxynorfentanyl and despropionylfentanyl in adolescent surgical patients with higher BMI percentiles.

  two years

Secondary Outcomes (1)

• to determine the frequency of the CYP3A5 genotype (*1 and *3 alleles) of all participants

  two years

Study Arms (1)

Fentanyl use for surgical pain

Adolescent patient having surgery

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Single, hospital based surgical center

You may qualify if:

• \. 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

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Vaughns JD, Ziesenitz VC, Williams EF, Mushtaq A, Bachmann R, Skopp G, Weiss J, Mikus G, van den Anker JN. Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery: A Pilot Study. Paediatr Drugs. 2017 Jun;19(3):251-257. doi: 10.1007/s40272-017-0216-6.

  PMID: 28238111 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John van den Anker, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-09

Locations

US (1)