Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Phase 2

Completed

• Conditions: Nausea and Vomiting
• Interventions: Drug: Ondansetron; Drug: Prochlorperazine

• Registration Number: NCT00590317
• Lead Sponsor: Emory University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2013-09-17
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Results First Posted: 2014-05-19
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron	Patient receiving Ondansetron 4mg IV
Prochlorperazine	Prochlorperazine	Patients receiving Prochlorperazine 10mg IV

Primary Outcome Measures

Name	Time	Method
Vomiting at 0 to 120 Min.	0 to 120 minutes after receiving medication

Secondary Outcome Measures

Name	Time	Method
Nausea at 0 to 120 Min	0 to 120 minutes after receiving medication	100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea
Akithisia at 0 to 120 Min	0 to 120 min after receiving medication

Trial Locations

Locations (2)

Grady Hospital; 🇺🇸 Atlanta, Georgia, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States