NCT03094754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

March 15, 2017

Last Update Submit

December 24, 2018

Conditions

Anesthesia, Endotracheal

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score

    postoperative pain score after nevi excision

    up to 3 hours

Secondary Outcomes (1)

  • emergence agitation score

    up to 3 hours

Interventions

nevi excisionPROCEDURE

After general anesthesia, nevi excision in children is performed.

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children undergoing nevi excision on general anesthesia

You may qualify if:

  • children undergoing nevi excision on general anesthesia

You may not qualify if:

  • development disorder
  • neurological disorder
  • psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, 16499, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant professor

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 29, 2017

Study Start

March 13, 2017

Primary Completion

January 25, 2018

Study Completion

January 25, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

KR(1)