Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00590317
• Collaborator: (none)
• Enrollment: 64
• Locations: 2
• Arms: 2
• Duration (Months): 42.1
• Patients Per Site: 32
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nausea and Vomiting	Drug: Prochlorperazine; Drug: Ondansetron	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prochlorperazine Patients receiving Prochlorperazine 10mg IV	Drug: Prochlorperazine; Patients receiving Prochlorperazine
Active Comparator: Ondansetron Patient receiving Ondansetron 4mg IV	Drug: Ondansetron; Patients receiving Ondansetron

Outcome Measures

Primary Outcome Measures

1. Vomiting at 0 to 120 Min. [0 to 120 minutes after receiving medication]

Secondary Outcome Measures

1. 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

2. Akithisia at 0 to 120 Min [0 to 120 min after receiving medication]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Hospital	Atlanta	Georgia	United States	30303
2	Grady Memorial Hospital	Atlanta	Georgia	United States

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: John Patka, PharmD, Grady Memorial Hospital
• Principal Investigator: Daniel T Wu, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Wu, MD, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT00590317
• Other Study ID Numbers: 0998-2005
• First Posted: Jan 10, 2008
• Last Update Posted: May 19, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Emergencies; Nausea; Vomiting; Ondansetron; Prochlorperazine

Study Results

Participant Flow

Recruitment Details	Patients were recruited at one site (Hospital Emergency Department)over a period of March 2005 to September 2008
Pre-assignment Detail	Patients were excluded if they chose to not participate after being enrolled and receiving medication but did not want to wait be observed for the 120 minute evaluation period.

Arm/Group Title	Prochlorperazine	Ondansetron
Arm/Group Description	Patients receiving Prochlorperazine 10 mg IV	Patients receiving Ondansetron 4mg IV
Period Title: Overall Study
STARTED	32	32
COMPLETED	31	27
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Prochlorperazine	Ondansetron	Total
Arm/Group Description	Patients receiving Prochlorperazine 10 mg IV	Patients receiving Ondansetron 4 mg IV	Total of all reporting groups
Overall Participants	32	32	64
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	32 100%	32 100%	64 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (12)	40 (11)	40 (12)
Sex: Female, Male (Count of Participants)
Female	17 53.1%	18 56.3%	35 54.7%
Male	15 46.9%	14 43.8%	29 45.3%
Region of Enrollment (participants) [Number]
United States	32 100%	32 100%	64 100%

Outcome Measures

1. Primary Outcome

Title	Vomiting at 0 to 120 Min.
Time Frame	0 to 120 minutes after receiving medication

Outcome Measure Data

Analysis Population Description

Convenience sample

Arm/Group Title	Prochlorperazine	Ondansetron
Arm/Group Description	Patients receiving Prochlorperazine 10mg IV	Patients receiving Ondansetron 4mg IV
Measure Participants	32	32
Number [number of participants exp vomiting]	1 3.1%	4 12.5%

2. Secondary Outcome

Title	Nausea at 0 to 120 Min
Description	100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea
Time Frame	0 to 120 minutes after receiving medication

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prochlorperazine	Ondansetron
Arm/Group Description	Patients receiving Prochlorperazine 10mg IV	Patients receiving Ondansetron 4mg IV
Measure Participants	32	32
Geometric Mean (Standard Deviation) [units on a scale]	16.8 (21.9)	34.3 (31.7)

3. Secondary Outcome

Title	Akithisia at 0 to 120 Min
Time Frame	0 to 120 min after receiving medication

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prochlorperazine	Ondansetron
Arm/Group Description	Patients receiving Prochlorperazine 10 mg IV	Patients receiving Ondansetron 4mg IV
Measure Participants	32	32
Number [no. participants exp akathisia]	3 9.4%	1 3.1%

Adverse Events

Arm/Group Title	Prochlorperazine		Ondansetron
Arm/Group Description	Patients receiving Prochlorperazine 10mg IV		Patients receiving Ondansetron 4mg IV
All Cause Mortality
	Prochlorperazine		Ondansetron
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Prochlorperazine		Ondansetron
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/32 (9.4%)		1/32 (3.1%)
Nervous system disorders
Akathisia	3/32 (9.4%)	3	1/32 (3.1%)	1
Other (Not Including Serious) Adverse Events
	Prochlorperazine		Ondansetron
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.