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

July 18, 2017 updated by: Arlyne Thung
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who presented for pyloromyotomy

Description

Inclusion Criteria:

  • patients who presented for pyloromyotomy

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IV Acetaminophen
Acetaminophen administered by intravenous infusion.
Drug: Acetaminophen
Acetaminophen given by IV
Other Names:
  • Ofirmev
Drug: Acetaminophen
Acetaminophen suppository given rectally
Other Names:
  • Acephen, Feverall
Rectal Acetaminophen
Acetaminophen administered by rectal suppository.
Drug: Acetaminophen
Acetaminophen given by IV
Other Names:
  • Ofirmev
Drug: Acetaminophen
Acetaminophen suppository given rectally
Other Names:
  • Acephen, Feverall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetaminophen Dosage
Time Frame: Baseline
One time in the OR prior to the start of surgery
Baseline
Average FLACC Pain Score in the PACU
Time Frame: 0-60 minutes post-operatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PACU Time
Time Frame: 45-60 minutes post-operatively
Time spent in the post-anesthesia care unit post-operatively.
45-60 minutes post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arlyne Thung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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