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Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

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Emory University

Status and phase

Completed
Phase 2

Conditions

Nausea and Vomiting

Treatments

Drug: Ondansetron
Drug: Prochlorperazine

Study type

Interventional

Funder types

Other

Identifiers

NCT00590317
0998-2005

Details and patient eligibility

About

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

Full 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

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

64 participants in 2 patient groups

Prochlorperazine
Active Comparator group
Description:
Patients receiving Prochlorperazine 10mg IV
Treatment:
Drug: Prochlorperazine
Ondansetron
Active Comparator group
Description:
Patient receiving Ondansetron 4mg IV
Treatment:
Drug: Ondansetron

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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