Nausea and Vomiting
Conditions
Brief summary
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.
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
Interventions
DRUGProchlorperazine
Patients receiving Prochlorperazine
DRUGOndansetron
Patients receiving Ondansetron
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vomiting at 0 to 120 Min. | 0 to 120 minutes after receiving medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Akithisia at 0 to 120 Min | 0 to 120 min after receiving medication | — |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at one site (Hospital Emergency Department)over a period of March 2005 to September 2008
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Prochlorperazine Patients receiving Prochlorperazine 10 mg IV | 32 |
| Ondansetron Patients receiving Ondansetron 4 mg IV | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 5 |
Baseline characteristics
| Characteristic | Ondansetron | Prochlorperazine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 32 Participants | 64 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 11 | 41 years STANDARD_DEVIATION 12 | 40 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 32 participants | 32 participants | 64 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 3 / 32 | 1 / 32 |
Outcome results
Primary
Vomiting at 0 to 120 Min.
Time frame: 0 to 120 minutes after receiving medication
Population: Convenience sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prochlorperazine | Vomiting at 0 to 120 Min. | 1 number of participants exp vomiting |
| Ondansetron | Vomiting at 0 to 120 Min. | 4 number of participants exp vomiting |
Secondary
Akithisia at 0 to 120 Min
Time frame: 0 to 120 min after receiving medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prochlorperazine | Akithisia at 0 to 120 Min | 3 no. participants exp akathisia |
| Ondansetron | Akithisia at 0 to 120 Min | 1 no. participants exp akathisia |
Secondary
Nausea at 0 to 120 Min
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Prochlorperazine | Nausea at 0 to 120 Min | 16.8 units on a scale | Standard Deviation 21.9 |
| Ondansetron | Nausea at 0 to 120 Min | 34.3 units on a scale | Standard Deviation 31.7 |