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

Pyloric Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359305
• Other study ID #: IRB14-00149
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: July 18, 2017
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients who presented for pyloromyotomy

Exclusion Criteria:

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Drug:
• Acetaminophen
Acetaminophen given by IV
• Acetaminophen
Acetaminophen suppository given rectally

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Arlyne Thung

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetaminophen Dosage	One time in the OR prior to the start of surgery	Baseline
Primary	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	PACU Time	Time spent in the post-anesthesia care unit post-operatively.	45-60 minutes post-operatively