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Completed

NCT Number: NCT00590317

Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

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

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Key information

Conditions

Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Grady Hospital, Atlanta, Georgia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prochlorperazine

Drug

Patients receiving Prochlorperazine

ondansetron

Drug

Patients receiving Ondansetron

Primary outcomes

  1. Vomiting at 0 to 120 Min.

    Time frame: 0 to 120 minutes after receiving medication

Secondary outcomes

  1. Nausea at 0 to 120 Min

    Time frame: 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

  2. Akithisia at 0 to 120 Min

    Time frame: 0 to 120 min after receiving medication

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 10, 2008
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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