Fentanyl Metabolism in Obese Adolescents

September 30, 2013 updated by: Janelle Vaughns, Children's National Research Institute

The Pharmacokinetics of Intravenous Fentanyl in Adolescent Patients With Higher BMI Percentiles.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Obesity represents one of the most important public health issues according to the World Health Organization. It has reached epidemic proportions globally, with approximately 1.5 billion overweight adults 20 years and older and at least 600 million of them clinically obese in 2008. According to the most recent NHANES survey (2003-2006), over two-third of the adults in the US are overweight or obese (overweight 68%, half of them obese) and about 17.6% of children and adolescents aged 12 to 19 were considered overweight or obese.

Obesity has also become an important challenge for the anesthesiologist. Safety and drug dosing particularly within the field of pediatric anesthesia, is of paramount concern as it can affect patient outcomes. Data collected in the United Kingdom from more than 100,000 anesthetized pediatric patients showed that a critical incident is twice as likely to occur in an obese child in the preoperative period as in an obese adult. A possible explanation may be linked to the lack of precision in drug dosing for these obese patients.

Fentanyl is a frequently used opioid analgesic in pediatric and adult anesthesia. Fentanyl is commonly administered to pediatric patients undergoing anesthesia as it is has a high potency, a rapid onset and a short duration of action. Due to these properties intravenously administered fentanyl is well suited as an analgesic compound in general anesthesia in pediatric patients.

The pharmacokinetics of fentanyl in adults have been well documented. Although there are some studies investigating the pharmacokinetic properties of oral, transmucosal and intravenous fentanyl preparations in children, the disposition of fentanyl in pediatric patients has not been sufficiently described. Several studies in infants and children report age-dependent differences in the pharmacokinetic/ pharmacodynamic parameters of intravenously administered fentanyl.

Currently there are no data available about the pharmacokinetics/ pharmacodynamics of fentanyl in adolescent obese patients.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Childrens National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Single, hospital based surgical center

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Fentanyl use for surgical pain
Adolescent patient having surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic clearance of fentanyl and its metabolites norfentanyl, hydroxynorfentanyl and despropionylfentanyl in adolescent surgical patients with higher BMI percentiles.
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
to determine the frequency of the CYP3A5 genotype (*1 and *3 alleles) of all participants
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Investigators

  • Principal Investigator: John van den Anker, MD, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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