Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Nausea and Vomiting Clinical Trial

Official title:

Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590317
• Other study ID #: 0998-2005
• Status: Completed
• Phase: Phase 2
• First received: December 27, 2007
• Last updated: April 23, 2014
• Start date: March 2005
• Est. completion date: September 2008

Study information

• Verified date: April 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Description:

Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.

Inclusion Criteria:

Patients presenting to the ED with at least one of the following

• nausea

• vomiting documented in the ED

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting to the ED with at least one of the following

• Nausea

• Vomiting documented in the ED

Exclusion Criteria:

• Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide

• Patients with missed last menstrual period

• Pregnancy

• Age < 18 years old

• Treatment with antineoplastic agents within 7 days prior to randomization

• Irritable bowel syndrome

• Gastroparesis

• Suspected gastrointestinal bleed

• Suspected intestinal obstruction

• Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)

• Traumatic brain injury upon admission to ED

• Intracranial hemorrhage upon admission to ED

• Patients unable to read, write or communicate in the English language

• Patients leaving the ED against medical advice

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Prochlorperazine
Patients receiving Prochlorperazine
• Ondansetron
Patients receiving Ondansetron

Locations

Country	Name	City	State
United States	Grady Hospital	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vomiting at 0 to 120 Min.		0 to 120 minutes after receiving medication	No
Secondary	Nausea at 0 to 120 Min	100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea	0 to 120 minutes after receiving medication	No
Secondary	Akithisia at 0 to 120 Min		0 to 120 min after receiving medication	No