IV Acetaminophen in Children Undergoing Palatoplasty

NCT ID: NCT01760330

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

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This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

Detailed Description

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Conditions

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Cleft Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IV acetaminophen

IV acetaminophen administered q 4 hrs. for a total of 24 hrs.

Group Type ACTIVE_COMPARATOR

IV acetaminophen

Intervention Type DRUG

Placebo

Normal saline administered IV every 4 hrs. for a total of 24 hrs.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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IV acetaminophen

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Ofirmev

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I or II
* Presenting for repair of palatoplasty with Drs. Kirschner or Pearson

Exclusion Criteria

* ASA physical status \> II
* Underlying Syndrome
* Significant co-morbid diseases (cardiac, pulmonary, neurological disease)
* Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tarun Bhalla, MD

Clinical Assistant Professor

Responsibility Role PRINCIPAL_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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IRB12-00709

Identifier Type: -

Identifier Source: org_study_id

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