Morbid ObesityNCT01955993
Fentanyl Metabolism in Obese Adolescents
An observational study of Morbid Obesity, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Single, hospital based surgical center
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbid Obesity
- Keywords
- Obesity, adolescence,pharmacokinetics,fentanyl
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl use for surgical pain | Adolescent patient having surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic clearance of fentanyl and its metabolites norfentanyl, hydroxynorfentanyl and despropionylfentanyl in adolescent surgical patients with higher BMI percentiles.
Measured: two years
Secondary outcomes (1)
to determine the frequency of the CYP3A5 genotype (*1 and *3 alleles) of all participants
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janelle Vaughns, Children's National Research Institute
- Investigators
- John van den Anker, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955993
- Sponsor's protocol ID
- 1809
- Status last verified
- Sep 2013
- First submitted
- 23 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28238111
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Intravenous Fentanyl in Adolescent Patients With Higher BMI Percentiles.
- ClinicalTrials.gov ID
- NCT01955993
- Acronym / sponsor ID
- 1809
- Conditions
- Morbid Obesity
- Keywords
- Obesity, adolescence,pharmacokinetics,fentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl use for surgical pain | – | –Adolescent patient having surgery |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Single, hospital based surgical center
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic clearance of fentanyl and its metabolites norfentanyl, hydroxynorfentanyl and despropionylfentanyl in adolescent surgical patients with higher BMI percentiles.
Time frame: two years
1 secondary outcome
to determine the frequency of the CYP3A5 genotype (*1 and *3 alleles) of all participants
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
- Derived from this study: PubMed 28238111Vaughns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John van den Anker, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic clearance of fentanyl and its metabolites norfentanyl, hydroxynorfentanyl and despropionylfentanyl in adolescent surgical patients with higher BMI percentiles. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.