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IV Acetaminophen in Children Undergoing Palatoplasty

Primary Purpose

Cleft Palate

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IV acetaminophen
Placebo
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IV acetaminophen

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain
Pain scores will be assessed.

Secondary Outcome Measures

Opioid consumption

Full Information

First Posted
December 12, 2012
Last Updated
March 4, 2016
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01760330
Brief Title
IV Acetaminophen in Children Undergoing Palatoplasty
Official Title
A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain funding
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV acetaminophen
Arm Type
Active Comparator
Arm Description
IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline administered IV every 4 hrs. for a total of 24 hrs.
Intervention Type
Drug
Intervention Name(s)
IV acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain
Description
Pain scores will be assessed.
Time Frame
24 hrs. post-op.
Secondary Outcome Measure Information:
Title
Opioid consumption
Time Frame
24 hrs. post-op

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

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IV Acetaminophen in Children Undergoing Palatoplasty

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