Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy
1 other identifier
observational
68
1 country
1
Brief Summary
This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
February 5, 2018
CompletedFebruary 5, 2018
April 1, 2017
2.1 years
July 31, 2014
April 12, 2017
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Acetaminophen Dosage
One time in the OR prior to the start of surgery
Baseline
Average FLACC Pain Score in the PACU
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.
0-60 minutes post-operatively
Secondary Outcomes (1)
PACU Time
45-60 minutes post-operatively
Study Arms (2)
IV Acetaminophen
Acetaminophen administered by intravenous infusion.
Rectal Acetaminophen
Acetaminophen administered by rectal suppository.
Interventions
Eligibility Criteria
Patients who presented for pyloromyotomy
You may qualify if:
- patients who presented for pyloromyotomy
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arlyne Thunglead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Arlyne Thung
- Organization
- Nationwide Children's Hospital - Dept. of Anesthesiology & Pain Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
July 31, 2014
First Posted
February 10, 2015
Study Start
June 1, 2014
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
February 5, 2018
Results First Posted
February 5, 2018
Record last verified: 2017-04