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NCT02732795 · ClinicalTrials.gov registry record · NA
Sleep Apnea and Obesity Affects on Morphine Pharmacokinetics
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT02732795: Completed NA study, sponsored by Johns Hopkins University.
NCT02732795 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02732795, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the leading cause for these procedures was recurrent infections; however, more recently surgical indications include sleep disordered breathing and obstructive sleep apnea (OSAS). Pre-operative polysomnography (PSG) is recommended for all children with suspected OSAS prior to undergoing AT, although it is unclear whether sleep disordered breathing characteristics predict post-operative outcomes or complications. Obesity has become an epidemic in the pediatric population. More recently, an increased population of obese children are presenting for AT with upper airway obstruction with or without tonsillar hypertrophy, which is similar to the adult etiology of OSAS. Obesity is a multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism, insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers for inflammation, including tumor necrosis factor (TNF)-α, C-reactive protein (CRP), leptin, interleukin (IL)-6 and IL-10, are abnormal in obese patients and have also been linked to more severe OSAS disease in children even after controlling for BMI. In pediatrics, medication dosing is based on an actual body-weight calculation, however, recent reports suggest that this dosing method is over-dosing patients with obesity. Therefore, increased respiratory complications after surgery may be related to inappropriate intra-operative opioid dosing. Specific Aim 1 (SA1): To compare morphine pharmacokinetics in normal children \<=12 years of age, non-obese children with severe OSAS, and obese children with severe OSAS. The investigators hypothesize that obesity independently enhances morphine pharmacokinetics. Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic inflammation, and OSAS predict changes to morphine
Interventions
- OTHER Morphine pharmacokinetic evaluation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-09-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02732795
The ClinicalTrials.gov registry entry for NCT02732795 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Morphine pharmacokinetic evaluation is the first listed.
NCT02732795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02732795 about?
NCT02732795 is a clinical study titled "Sleep Apnea and Obesity Affects on Morphine Pharmacokinetics". Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the leading cause for these procedures was recurrent infections; however, more recently surgical indications include sleep...
What is the current status of trial NCT02732795?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2015-07. Estimated completion is 2018-09-07.
What interventions are being tested in trial NCT02732795?
The interventions under investigation include: Morphine pharmacokinetic evaluation (OTHER).
Who is sponsoring clinical trial NCT02732795?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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