Trial Outcomes & Findings for Tylenol Levels in Bariatric Patients (NCT NCT02982928)
NCT ID: NCT02982928
Last Updated: 2019-06-19
Results Overview
To determine whether adequate serum concentration of acetaminophen is achieved.
Recruitment status
COMPLETED
Target enrollment
11 participants
Primary outcome 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
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Bariatric Surgery
Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tylenol Levels in Bariatric Patients
Baseline characteristics by cohort
| Measure |
Bariatric Surgery
n=11 Participants
Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
BMI (kg/m2)
|
46 Kg/m2
STANDARD_DEVIATION 5 • n=5 Participants
|
PRIMARY outcome
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 administrationTo determine whether adequate serum concentration of acetaminophen is achieved.
Outcome measures
| Measure |
Bariatric Surgery
n=11 Participants
Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).
|
|---|---|
|
Intra- and Post-operative Serum Concentrations
4 hours
|
0 µg.mL-1
Standard Deviation 0
|
|
Intra- and Post-operative Serum Concentrations
8 hours
|
0 µg.mL-1
Standard Deviation 0
|
|
Intra- and Post-operative Serum Concentrations
12 hours
|
0 µg.mL-1
Standard Deviation 0
|
|
Intra- and Post-operative Serum Concentrations
15-20 minutes
|
17 µg.mL-1
Standard Deviation 4
|
|
Intra- and Post-operative Serum Concentrations
30-40 minutes
|
14 µg.mL-1
Standard Deviation 3
|
|
Intra- and Post-operative Serum Concentrations
50-70 minutes
|
9 µg.mL-1
Standard Deviation 6
|
|
Intra- and Post-operative Serum Concentrations
80-100 minutes
|
5 µg.mL-1
Standard Deviation 6
|
|
Intra- and Post-operative Serum Concentrations
2 hours
|
0 µg.mL-1
Standard Deviation 0
|
Adverse Events
Bariatric Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place