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Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy

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ClinicalTrials.gov Identifier: NCT02359305
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition Pyloric Stenosis
Intervention Drug: Acetaminophen
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Rectal Acetaminophen
Hide Arm/Group Description Acetaminophen given by intravenous infusion. Acetaminophen given by rectal suppository.
Period Title: Overall Study
Started 34 34
Completed 34 34
Not Completed 0 0
Arm/Group Title IV Acetaminophen Rectal Acetaminophen Total
Hide Arm/Group Description Acetaminophen administered by intravenous infusion. Acetaminophen administered by rectal suppository. Total of all reporting groups
Overall Number of Baseline Participants 34 34 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 68 participants
<=18 years
34
 100.0%
34
 100.0%
68
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 34 participants 34 participants 68 participants
34.2  (14.5) 37.8  (16.5) 36  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 68 participants
Female
5
  14.7%
5
  14.7%
10
  14.7%
Male
29
  85.3%
29
  85.3%
58
  85.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 34 participants 68 participants
34 34 68
1.Primary Outcome
Title Acetaminophen Dosage
Hide Description One time in the OR prior to the start of surgery
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Rectal Acetaminophen
Hide Arm/Group Description:
Acetaminophen administered by intravenous infusion.
Acetaminophen administered by rectal suppository.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: mg/kg
8.6  (3.9) 30.7  (6.3)
2.Primary Outcome
Title Average FLACC Pain Score in the PACU
Hide Description The 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.
Time Frame 0-60 minutes post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Rectal Acetaminophen
Hide Arm/Group Description:
Acetaminophen administered by intravenous infusion.
Acetaminophen administered by rectal suppository.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-10
0.3  (0.6) 0.6  (1)
3.Secondary Outcome
Title PACU Time
Hide Description Time spent in the post-anesthesia care unit post-operatively.
Time Frame 45-60 minutes post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Rectal Acetaminophen
Hide Arm/Group Description:
Acetaminophen administered by intravenous infusion.
Acetaminophen administered by rectal suppository.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: minutes
48  (19.9) 50.4  (12)
Time Frame During hospital stay following surgery (average 1-3 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Rectal Acetaminophen
Hide Arm/Group Description Acetaminophen administered by intravenous infusion. Acetaminophen administered by rectal suppository.
All-Cause Mortality
IV Acetaminophen Rectal Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen Rectal Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Acetaminophen Rectal Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Arlyne Thung
Organization: Nationwide Children's Hospital - Dept. of Anesthesiology & Pain Medicine
Phone: 614-722-4200
EMail: Arlyne.Thung@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Arlyne Thung, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02359305     History of Changes
Other Study ID Numbers: IRB14-00149
First Submitted: July 31, 2014
First Posted: February 10, 2015
Results First Submitted: April 12, 2017
Results First Posted: February 2, 2018
Last Update Posted: February 2, 2018