Trial Outcomes & Findings for Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department (NCT NCT00590317)

NCT ID: NCT00590317

Last Updated: 2014-05-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: 0 to 120 minutes after receiving medication
• Results posted on: 2014-05-19

Participant Flow

Patients were recruited at one site (Hospital Emergency Department)over a period of March 2005 to September 2008

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.

Participant milestones

Measure	Prochlorperazine Patients receiving Prochlorperazine 10 mg IV	Ondansetron Patients receiving Ondansetron 4mg IV
Overall Study STARTED	32	32
Overall Study COMPLETED	31	27
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	Prochlorperazine Patients receiving Prochlorperazine 10 mg IV	Ondansetron Patients receiving Ondansetron 4mg IV
Overall Study Lack of Efficacy	1	5

Baseline Characteristics

Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Baseline characteristics by cohort

Measure	Prochlorperazine n=32 Participants Patients receiving Prochlorperazine 10 mg IV	Ondansetron n=32 Participants Patients receiving Ondansetron 4 mg IV	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 12 • n=5 Participants	40 years STANDARD_DEVIATION 11 • n=7 Participants	40 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	32 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 120 minutes after receiving medication

Population: Convenience sample

Outcome measures

Measure	Prochlorperazine n=32 Participants Patients receiving Prochlorperazine 10mg IV	Ondansetron n=32 Participants Patients receiving Ondansetron 4mg IV
Vomiting at 0 to 120 Min.	1 number of participants exp vomiting	4 number of participants exp vomiting

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Prochlorperazine n=32 Participants Patients receiving Prochlorperazine 10mg IV	Ondansetron n=32 Participants Patients receiving Ondansetron 4mg IV
Nausea at 0 to 120 Min	16.8 units on a scale Standard Deviation 21.9	34.3 units on a scale Standard Deviation 31.7

SECONDARY outcome

Timeframe: 0 to 120 min after receiving medication

Outcome measures

Measure	Prochlorperazine n=32 Participants Patients receiving Prochlorperazine 10mg IV	Ondansetron n=32 Participants Patients receiving Ondansetron 4mg IV
Akithisia at 0 to 120 Min	3 no. participants exp akathisia	1 no. participants exp akathisia

Adverse Events

Prochlorperazine

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Ondansetron

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prochlorperazine n=32 participants at risk Patients receiving Prochlorperazine 10mg IV	Ondansetron n=32 participants at risk Patients receiving Ondansetron 4mg IV
Nervous system disorders Akathisia	9.4% 3/32 • Number of events 3	3.1% 1/32 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Wu

Emory University

Phone: (404) 251-8875

Email: dtwu@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place