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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02359305
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Pyloric Stenosis Drug: Acetaminophen

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Actual Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
IV Acetaminophen
Acetaminophen administered by intravenous infusion.
Drug: Acetaminophen
Acetaminophen given by IV
Other Name: Ofirmev

Rectal Acetaminophen
Acetaminophen administered by rectal suppository.
Drug: Acetaminophen
Acetaminophen suppository given rectally
Other Name: Acephen, Feverall

Primary Outcome Measures :
  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 Outcome Measures :
  1. PACU Time [ Time Frame: 45-60 minutes post-operatively ]
    Time spent in the post-anesthesia care unit post-operatively.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who presented for pyloromyotomy

Inclusion Criteria:

  • patients who presented for pyloromyotomy

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02359305

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Arlyne Thung

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Responsible Party: Arlyne Thung, Clinical Assistant Professor, Nationwide Children's Hospital Identifier: NCT02359305    
Other Study ID Numbers: IRB14-00149
First Posted: February 10, 2015    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: April 2017
Additional relevant MeSH terms:
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Pyloric Stenosis
Gastric Outlet Obstruction
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs