Chloroprocaine for Continuous Epidural Analgesia in Neona... | NCT02207855

Studies
Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants

NCT02207855

Sponsor

Joseph D. Tobias

Status

Completed

Last Update Posted

Nov 29, 2016Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Chloroprocaine

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Aug 1, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 4, 2014Estimated

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

Nov 28, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Joseph D. TobiasOTHER

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 a study to retrospectively review our experience with the use of chloroprocaine for postoperative epidural infusions in neonates and infants. Pain scores and the need for intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of the technique.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chloroprocaine		Neonates and infants who have received chloroprocaine for epidural anesthesia.	Drug: Chloroprocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chloroprocaine	Drug		Chloroprocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score		Every 6 hours for 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Pain medicine consumption		Every 6 hours for 72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neonates and infants who have received chloroprocaine for epidural anesthesia.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

Neonates and infants who have received chloroprocaine for epidural anesthesia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph D Tobias, MD	Nationwide Children's Hospital	Principal Investigator

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
C004616	chloroprocaine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided