Tylenol Levels in Bariatric Patients

Nationwide Children's Hospital

Status: Completed

Conditions: Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT02982928

IRB15-00471

Details and patient eligibility

About

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

Full description

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.

Enrollment: 11 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design