Skip to main content
OpenTrials
Completed

NCT Number: NCT02359305

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pyloric Stenosis Digestive System Diseases Gastric Outlet Obstruction Gastrointestinal Diseases Stomach Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who presented for pyloromyotomy

Exclusion criteria

  • none

Treatment and study plan

Acetaminophen

Drug

Acetaminophen given by IV

Other names: Ofirmev

Primary outcomes

  1. Acetaminophen Dosage

    Time frame: Baseline

    One time in the OR prior to the start of surgery

  2. 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.

Secondary outcomes

  1. PACU Time

    Time frame: 45-60 minutes post-operatively

    Time spent in the post-anesthesia care unit post-operatively.

Sponsors and collaborators

Lead sponsor

Arlyne Thung

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2015
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.