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

NCT ID: NCT02359305

Last Updated: 2018-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pyloric Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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IV Acetaminophen

Acetaminophen administered by intravenous infusion.

Acetaminophen

Intervention Type DRUG

Acetaminophen given by IV

Rectal Acetaminophen

Acetaminophen administered by rectal suppository.

Acetaminophen

Intervention Type DRUG

Acetaminophen suppository given rectally

Interventions

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Acetaminophen

Acetaminophen given by IV

Intervention Type DRUG

Acetaminophen

Acetaminophen suppository given rectally

Intervention Type DRUG

Other Intervention Names

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Ofirmev Acephen, Feverall

Eligibility Criteria

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Inclusion Criteria

* patients who presented for pyloromyotomy

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arlyne Thung

OTHER

Sponsor Role lead

Responsible Party

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Arlyne Thung

Clinical Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB14-00149

Identifier Type: -

Identifier Source: org_study_id

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