IV Acetaminophen in Children Undergoing Palatoplasty | NCT01760330

Studies
IV Acetaminophen in Children Undergoing Palatoplasty

NCT01760330

Sponsor

Nationwide Children's Hospital

Status

Withdrawn

Last Update Posted

Mar 8, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Cleft Palate

Interventions

IV acetaminophen
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to obtain funding

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2016

Last Update Posted Date

Mar 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarun Bhalla, MD, Clinical Assistant Professor, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IV acetaminophen	Active Comparator	IV acetaminophen administered q 4 hrs. for a total of 24 hrs.	Drug: IV acetaminophen
Placebo	Placebo Comparator	Normal saline administered IV every 4 hrs. for a total of 24 hrs.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV acetaminophen	Drug		IV acetaminophen	Ofirmev
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain scores will be assessed.	24 hrs. post-op.

Secondary Outcomes

Measure	Description	Time Frame
Opioid consumption		24 hrs. post-op

Other Outcomes

Not provided

Eligibility Module

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D002972	Cleft Palate

Ancestor Terms

ID	Term
D007569	Jaw Abnormalities
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D019767	Maxillofacial Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided