NCT01527890

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

January 27, 2012

Last Update Submit

February 2, 2012

Conditions

Keywords

intravenous patient-controlled analgesiaIV PCA

Interventions

intravenous patient-controlled analgesia

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, 125-070, South Korea

RECRUITING

MeSH Terms

Conditions

NauseaVomiting

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Yon Hee Shim, MD, PhD

CONTACT

Jong Bum Choi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yonsei University College of Medicine

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 7, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations