Trial Outcomes & Findings for Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy (NCT NCT02359305)
NCT ID: NCT02359305
Last Updated: 2018-02-05
Results Overview
One time in the OR prior to the start of surgery
COMPLETED
68 participants
Baseline
2018-02-05
Participant Flow
Participant milestones
| Measure |
IV Acetaminophen
Acetaminophen given by intravenous infusion.
|
Rectal Acetaminophen
Acetaminophen given by rectal suppository.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy
Baseline characteristics by cohort
| Measure |
IV Acetaminophen
n=34 Participants
Acetaminophen administered by intravenous infusion.
|
Rectal Acetaminophen
n=34 Participants
Acetaminophen administered by rectal suppository.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.2 days
STANDARD_DEVIATION 14.5 • n=5 Participants
|
37.8 days
STANDARD_DEVIATION 16.5 • n=7 Participants
|
36 days
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineOne time in the OR prior to the start of surgery
Outcome measures
| Measure |
IV Acetaminophen
n=34 Participants
Acetaminophen administered by intravenous infusion.
|
Rectal Acetaminophen
n=34 Participants
Acetaminophen administered by rectal suppository.
|
|---|---|---|
|
Acetaminophen Dosage
|
8.6 mg/kg
Standard Deviation 3.9
|
30.7 mg/kg
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: 0-60 minutes post-operativelyThe Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.
Outcome measures
| Measure |
IV Acetaminophen
n=34 Participants
Acetaminophen administered by intravenous infusion.
|
Rectal Acetaminophen
n=34 Participants
Acetaminophen administered by rectal suppository.
|
|---|---|---|
|
Average FLACC Pain Score in the PACU
|
0.3 units on a scale 0-10
Standard Deviation 0.6
|
0.6 units on a scale 0-10
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 45-60 minutes post-operativelyTime spent in the post-anesthesia care unit post-operatively.
Outcome measures
| Measure |
IV Acetaminophen
n=34 Participants
Acetaminophen administered by intravenous infusion.
|
Rectal Acetaminophen
n=34 Participants
Acetaminophen administered by rectal suppository.
|
|---|---|---|
|
PACU Time
|
48 minutes
Standard Deviation 19.9
|
50.4 minutes
Standard Deviation 12
|
Adverse Events
IV Acetaminophen
Rectal Acetaminophen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Arlyne Thung
Nationwide Children's Hospital - Dept. of Anesthesiology & Pain Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place