Clinical trial NCT02982928: Tylenol Levels in Bariatric Patients
Official title: Acetaminophen Pharmacokinetics in Bariatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Bariatrics
Acetaminophen
robot-assisted or laparoscopic bariatric surgery
Pharmacokinetics
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 30 patients presenting to the OR for robotic assisted or laparoscopic bariatric surgery.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intra- and Post-operative Serum Concentrations
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Ahsan Syed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.
citation: Saurabh S, Smith JK, Pedersen M, Jose P, Nau P, Samuel I. Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):424-30. doi: 10.1016/j.soard.2014.09.017. Epub 2014 Sep 30.
citation: Abernethy DR, Divoll M, Greenblatt DJ, Ameer B. Obesity, sex, and acetaminophen disposition. Clin Pharmacol Ther. 1982 Jun;31(6):783-90. doi: 10.1038/clpt.1982.111.
citation: Lee WH, Kramer WG, Granville GE. The effect of obesity on acetaminophen pharmacokinetics in man. J Clin Pharmacol. 1981 Jul;21(7):284-7. doi: 10.1002/j.1552-4604.1981.tb01768.x.
citation: Birmingham PK, Tobin MJ, Henthorn TK, Fisher DM, Berkelhamer MC, Smith FA, Fanta KB, Cote CJ. Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations. Anesthesiology. 1997 Aug;87(2):244-52. doi: 10.1097/00000542-199708000-00010.