Effect of Intravenous Patient-controlled Analgesia (IV-PC... | NCT01527890

Studies
Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control

NCT01527890

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Feb 7, 2012Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Nausea
Vomiting

Interventions

Fentanyl

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

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Sep 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Jan 27, 2012

First Submission Date that Met QC Criteria

Feb 2, 2012

First Posted Date

Feb 7, 2012Estimated

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

Feb 2, 2012

Last Update Posted Date

Feb 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yon Hee Shim, Yonsei University College of Medicine, Yonsei UniversityPrincipal Investigator

Lead Sponsor

Yonsei UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

In this retrospective study, the investigators examined incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA).

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

Not provided

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

2,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug	intravenous patient-controlled analgesia

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults between 20 to 60 years old
Date from 1st, May 2011 to 31st, October 2011
Patients with fentanyl based intravenous patient-controlled analgesia for postoperative pain control

Exclusion Criteria:

Reoperation within 48 hours
Patients who cannot express numerical rating scale for pain due to sedation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients with Intravenous Fentanyl Patient-controlled Analgesia for postoperative pain control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yon Hee Shim, MD, PhD	Contact	82-2-2019-3547	3547	tren125@yuhs.ac
Jong Bum Choi, MD	Contact	82-2-2019-3528		romeojb@naver.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangnam Severance Hospital	Recruiting	Seoul		125-070	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided