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OpenTrials
Completed

NCT Number: NCT02982928

Tylenol Levels in Bariatric Patients

The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.

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Key information

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

This will be a descriptive study carried out by study staff from the anesthesiology department. The patient population will include obese patients scheduled for robot-assisted or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for these patients. Volume of distribution and elimination half-life of acetaminophen in serum samples are the primary measurements of the study. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 12, but younger than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery
  • American Society of Anesthesiologists Physical Status Classification System (ASA) I, II or III
  • Parent/guardian willing and able to give consent
  • Patient willing to give assent, or consent
  • Patients that are otherwise healthy at the discretion of the study staff
  • Patients with BMI >95th percentile

Exclusion criteria

  • Patients with severe right heart failure or severe asthma
  • Patients with deficient hepatic function that can affect drug metabolism
  • Systemic steroid use within the last 3 months
  • Patients who have taken acetaminophen containing medications within 24 hours of surgery date
  • Patients younger than 12, but older than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery
  • Patients having other procedures in addition to robotic assisted or laparoscopic bariatric surgery
  • American Society of Anesthesiologists Physical Status Classification System (ASA) IV and above
  • Females testing positive for pregnancy
  • Parent/guardian not willing and able to give assent, or consent
  • Patient not willing to give assent, or consent
  • Patients with BMI < 95th percentile

Treatment and study plan

Primary outcomes

  1. Intra- and Post-operative Serum Concentrations

    Time frame: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration

    To determine whether adequate serum concentration of acetaminophen is achieved.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Acetaminophen Pharmacokinetics in Bariatric Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2016
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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