Dataset Information

Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery: A Pilot Study.

ABSTRACT: BACKGROUND:The number of obese pediatric patients requiring anesthesia is rapidly increasing. Although fentanyl is a commonly used narcotic during surgery, there are no pharmacokinetic (PK) data available for optimal dosing of fentanyl in adolescents with clinically severe obesity. MATERIALS AND METHODS:An institutional review board-approved exploratory pilot study was conducted in six adolescents aged 14-19 years undergoing bariatric surgery. Mean total body weight (TBW) and mean BMI were 137.4 ± 14.3 kg and 49.6 ± 6.4 kg/m2 (99.5th BMI percentile), respectively. Fentanyl was administered intravenously for intraoperative analgesia based on ideal body weight per standard of care. PK blood samples were drawn over a 24-h post-dose period. Fentanyl PK parameters were calculated by non-compartmental analysis. RESULTS:Mean fentanyl AUC0-? was 1.5 ± 0.5 h·ng/mL. Systemic clearance of fentanyl was 1522 ± 310 mL/min and 11.2 ± 2.6 mL/min·kg TBW. Volume of distribution was 635 ± 282 L and 4.7 ± 2.1 L/kg TBW. While absolute clearance was increased, absolute volume of distribution was comparable to previously established adult values. CONCLUSIONS:These results suggest that fentanyl clearance is enhanced in adolescents with clinically severe obesity while volume of distribution is comparable to previously published studies. STUDY REGISTRATION:NCT01955993 (clinicaltrials.gov).

SUBMITTER: Vaughns JD

PROVIDER: S-EPMC5861708 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery: A Pilot Study.

Vaughns Janelle D JD Ziesenitz Victoria C VC Williams Elaine F EF Mushtaq Alvina A Bachmann Ricarda R Skopp Gisela G Weiss Johanna J Mikus Gerd G van den Anker Johannes N JN

Paediatric drugs 20170601 3

<h4>Background</h4>The number of obese pediatric patients requiring anesthesia is rapidly increasing. Although fentanyl is a commonly used narcotic during surgery, there are no pharmacokinetic (PK) data available for optimal dosing of fentanyl in adolescents with clinically severe obesity.<h4>Materials and methods</h4>An institutional review board-approved exploratory pilot study was conducted in six adolescents aged 14-19 years undergoing bariatric surgery. Mean total body weight (TBW) and mean ...[more]

PMID: 28238111

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Project description:Inflammation, oxidative stress and dysregulation of adipokines are thought to be pathophysiological mechanisms linking obesity to the development of insulin resistance and atherosclerosis. In adults, bariatric surgery reduces inflammation and oxidative stress, and beneficially changes the levels of several adipokines, but little is known about the postsurgical changes among adolescents.In two separate longitudinal cohorts we evaluated change from baseline of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), monocyte chemo-attractant protein-1 (MCP-1), oxidized low-density lipoprotein cholesterol (oxLDL), adiponectin, leptin and resistin up to 12 months following elective laparoscopic Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG) surgery in adolescents with severe obesity.In cohort 1, which consisted of 39 adolescents (mean age 16.5±1.6 years; 29 females) undergoing either RYGB or VSG, IL-6 (baseline: 2.3±3.4 pg ml(-1) vs 12 months: 0.8±0.6 pg ml(-1), P<0.01), leptin (baseline: 178±224 ng ml(-1) vs 12 months: 41.4±31.9 ng ml(-1), P<0.001) and oxLDL (baseline: 41.6±11.6 U l(-1) vs 12 months: 35.5±11.1 U l(-1), P=0.001) significantly decreased and adiponectin significantly increased (baseline: 5.4±2.4 μg ml(-1) vs 12 months: 13.5±8.9 μg ml(-1), P<0.001). In cohort 2, which consisted of 13 adolescents (mean age 16.5±1.6 years; 10 females) undergoing RYGB, results were similar: IL-6 (baseline: 1.7±0.9 pg ml(-1) vs 12 months: 0.4±0.9 pg ml(-1), P<0.05) and leptin (baseline: 92.9±31.3 ng ml(-1) vs 12 months: 37.3±33.4 ng ml(-1), P<0.001) significantly decreased and adiponectin significantly increased (baseline: 6.1±2.9 μg ml(-1) vs 12 months: 15.4±8.0 μg ml(-1), P<0.001). When the cohorts were combined to evaluate changes at 12 months, oxLDL also significantly decreased (baseline: 39.8±16.7 U l(-1) vs 12 months: 32.7±11.9 U l(-1), P=0.03).Bariatric surgery produced robust improvements in markers of inflammation, oxidative stress and several adipokines among adolescents with severe obesity, suggesting potential reductions in risk for type 2 diabetes and cardiovascular disease.

Project description:BACKGROUND/OBJECTIVES:We hypothesized that physical activity (PA) improves insulin sensitivity in adolescents with severe obesity beyond that attributable to metabolic bariatric surgery (MBS). SUBJECTS/METHODS:StepWatchTM monitors objectively measured PA in 88 participants in the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. Primary outcomes included absolute change in fasting insulin, HOMA-IR, and fasting glucose from pre-surgery (baseline) to 6, 12, 24, and 36 months post-MBS. SAS PROC TRAJ generated activity trajectories based on probability and individual participant step count trajectories. Linear regression models were used, adjusted for baseline value, visit, surgical procedure, sex, and percent change in BMI. Additional models adjusted for percent change in iliac waist circumference (IWC) or percent body fat (BF), measured by bio-impedance. RESULTS:Two activity trajectories were identified: more active (MA, n = 13) and less active (LA, n = 75). MA baseline mean daily step count was >6000, increasing to >9000 at 2 years. LA mean daily step count remained at ~4000. Few participants recorded moderate step activity (cadence >80 steps/minute). Still, fasting insulin and HOMA-IR differed in association with activity trajectoy. MA was associated with a greater absolute decrease in fasting insulin (-7.8 ?U/ml [95% CI: (-11.8, -3.7)], p???0.001) and a greater decrease in HOMA-IR (-1.9 [95% CI: (-3.0, -0.7)], p = 0.001), when adjusted for percent change in BMI. The significant independent effect of MA remained when adjusted for percent change in IWC or percent BF. Clinically, 100% of MA trajectory participants normalized fasting insulin, HOMA-IR, and fasting glucose by 6 months and normalization remained throughout the 36 months follow up. In contrast, 76.3 and 65.8% of LA trajectory participants normalized fasting insulin and HOMA-IR, respectively, by 12 months with 28.6% of both remaining normalized at 36 months. CONCLUSIONS:PA is independently associated with improved insulin sensitivity beyond that attributable to MBS in adolescents with severe obesity.

Project description:BackgroundParental underestimation of the severity and risks of their child's obesity and parents' potential implicit weight bias contribute to the reluctance to consider bariatric surgery for their adolescent children with obesity. Despite evidence for safety and efficacy of bariatric surgery in adolescents, pediatric providers may be hesitant or uncomfortable to discuss the benefits and refer patients for surgical evaluation. Understanding these barriers is an essential step toward effective long-term care in this patient population.ObjectivesWe hypothesized that parental views on bariatric surgery are primarily influenced by personal experiences with bariatric surgery, their implicit bias, understanding of health risks of obesity, and counseling by pediatric providers.SettingData were collected and analyzed at an academic medical center in the United States.MethodsAfter a retrospective chart review of 192 adolescents with obesity, a telephone survey of patients' parents was conducted.ResultsParents of 71.4% of patients who received outpatient weight loss counseling had accurate recollection of that event. Only 12.8% of parents who were referred to lifestyle programs successfully enrolled. Neither prior personal exposure to bariatric surgery nor enrollment of the child in a lifestyle program increased parents' likelihood to consider bariatric surgery for their child (P = .10 and .70, respectively). Most parents (84.6%) who were counseled by their pediatric provider about bariatric surgery would consider it, compared with only 34.5% of the parents who did not receive counseling (P < .001).ConclusionsCounseling by pediatric providers, not involvement in lifestyle programs or exposure to bariatric surgery, increased parents' willingness to consider bariatric surgery for their child. Given the current recommendations to incorporate bariatric surgery as a treatment modality in severe adolescent obesity, earlier counseling about the role of surgery by pediatric providers is essential. More detailed provider education on the current state of bariatric surgery in the treatment of severe adolescent obesity is also necessary.

Project description:Severe obesity in childhood is a major health problem with few effective treatments. Weight-loss surgery (WLS) is being used to treat severely obese adolescents, although with very limited data regarding surgical safety for currently used, minimally invasive procedures.To assess the preoperative clinical characteristics and perioperative safety outcomes of severely obese adolescents undergoing WLS.This prospective, multisite observational study enrolled patients from February 28, 2007, through December 30, 2011. Consecutive patients aged 19 years or younger who were approved to undergo WLS (n?=?277) were offered enrollment into the study at 5 academic referral centers in the United States; 13 declined participation and 22 did not undergo surgery after enrollment, thus the final analysis cohort consisted of 242 individuals. There were no withdrawals.This analysis examined preoperative anthropometrics, comorbid conditions, and major and minor complications occurring within 30 days of operation. All data were collected in a standardized fashion. Reoperations and hospital readmissions were adjudicated by independent reviewers to assess relatedness to the WLS procedure.The mean (SD) age of participants was 17.1 (1.6) years and the median body mass index (calculated as weight in kilograms divided by height in meters squared) was 50.5. Fifty-one percent demonstrated 4 or more major comorbid conditions. Laparoscopic Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and adjustable gastric banding were performed in 66%, 28%, and 6% of patients, respectively. There were no deaths during the initial hospitalization or within 30 days of operation; major complications (eg, reoperation) were seen in 19 patients (8%). Minor complications (eg, readmission for dehydration) were noted in 36 patients (15%). All reoperations and 85% of readmissions were related to WLS.In this series, adolescents with severe obesity presented with abundant comorbid conditions. We observed a favorable short-term complication profile, supporting the early postoperative safety of WLS in select adolescents. Further longitudinal study of this cohort will permit accurate assessment of long-term outcomes for adolescents undergoing bariatric surgery.clinicaltrials.gov Identifier: NCT00474318.

Dataset Information

Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery: A Pilot Study.

Publications

Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery: A Pilot Study.

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