Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

Postoperative Pain Clinical Trial

— Apfel-PDNV  

Official title:

Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514878
• Other study ID #: H54427-30684
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: October 30, 2009
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary purpose of this prospective cohort study is to develop a simplified risk model for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US that will allow clinicians to identify those patients who would benefit from prophylactic antiemetic strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• scheduled for an elective outpatient surgical procedure

• understands the nature and purpose of this survey and has signed an informed consent form

• willing and able to complete daily components of the Patient Diary from the day of surgery until the end of the 48 hour assessment

• undergoing general anesthesia requiring a tracheal tube or laryngeal mask airway

Exclusion Criteria:

• planned inpatient surgery

• inability to communicate in English

• regional anesthesia alone without general anesthesia, as PONV in this setting is known to be significantly lower [18, 19]

• persistent or recurrent nausea and/or vomiting before anesthesia due to other etiologies, unless clearly related only to the anxiety due to impending surgery

• minors (< 18 years of age)

• current pregnancy by self-report (potentially confounding for etiology of nausea)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postdischarge Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Locations

Country	Name	City	State
United States	Perioperative Clinical Research Core, University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,