Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

NCT00590317 | Completed Phase 2 Results

• 1 other identifier: 0998-2005
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Vomiting at 0 to 120 Min.

  0 to 120 minutes after receiving medication

Secondary Outcomes (2)

• Nausea at 0 to 120 Min

  0 to 120 minutes after receiving medication

• Akithisia at 0 to 120 Min

  0 to 120 min after receiving medication

Study Arms (2)

Prochlorperazine

ACTIVE COMPARATOR

Patients receiving Prochlorperazine 10mg IV

Drug: Prochlorperazine

Ondansetron

ACTIVE COMPARATOR

Patient receiving Ondansetron 4mg IV

Drug: Ondansetron

Interventions

Prochlorperazine DRUG

Patients receiving Prochlorperazine

Prochlorperazine

Ondansetron DRUG

Patients receiving Ondansetron

Ondansetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting to the ED with at least one of the following
• Nausea
• Vomiting documented in the ED

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Hospital

Atlanta, Georgia, 30303, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Prochlorperazine; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring

Limitations and Caveats

Small sample size due to limited enrollment. Fewer patient in the Odansetron group were discharged home suggesting a possibly sicker baseline group. Complete data sets were not available for all patients due to sedation and participation.

Results Point of Contact

• Title: Dr. Daniel Wu
• Organization: Emory University

dtwu@emory.edu

(404) 251-8875

Study Officials

• John Patka, PharmD

  Grady Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Daniel T Wu, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 10, 2008
• Study Start: March 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 19, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-04

Locations

US (2)