N/A
N=11
Tylenol Levels in Bariatric Patients
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02982928 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Intra- and Post-operative Serum Concentrations — 17; 14; 9; 5 µg.mL-1
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra- and Post-operative Serum Concentrations |
17; 14; 9; 5; 0; 0 | — |
Summary
The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.
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
Data sourced from ClinicalTrials.gov (NCT02982928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.