Excision Size and Location on the Postoperative Pain Afte... | NCT03094754

Studies
Excision Size and Location on the Postoperative Pain After Nevi Excision in Children

NCT03094754

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Dec 26, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Anesthesia, Endotracheal

Interventions

nevi excision

Countries

South Korea

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

Dec 2018

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

Mar 13, 2017Actual

Primary Completion Date

Jan 25, 2018Actual

Completion Date

Jan 25, 2018Actual

First Submitted Date

Mar 15, 2017

First Submission Date that Met QC Criteria

Mar 28, 2017

First Posted Date

Mar 29, 2017Actual

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

Dec 24, 2018

Last Update Posted Date

Dec 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Eun Kim, Assitant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the postoperative pain after nevi excision in children.

The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the emergence excitation after nevi excision in children.

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

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nevi excision	Procedure	After general anesthesia, nevi excision in children is performed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pain score	postoperative pain score after nevi excision	up to 3 hours

Secondary Outcomes

Measure	Description	Time Frame
emergence agitation score	emergence agitation score after nevi excision	up to 3 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children undergoing nevi excision on general anesthesia

Exclusion Criteria:

development disorder
neurological disorder
psychological disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

7 Years

Standard Ages

Child

Study Population

children undergoing nevi excision on general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine		Suwon	Seoum	16499	South Korea