Cyclic Vomiting Syndrome
Conditions
Brief summary
The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.
Interventions
DRUGDroperidol
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
DRUGHaloperidol
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
DRUGOndansetron 8mg
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron
Sponsors
Corewell Health South
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adult patients with clinical diagnosis of cyclic vomiting in the ED
Exclusion criteria
* pregnancy, allergy to any of the study medicines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain | 2 hours | change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale |
| Nausea | 2 hours | change in nausea on 0 (none) through 10 (worse possible nausea) on a scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | 2 hours | both abdominal pain and nausea scores under 2 (none or minimal) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Haloperidol these patients will receive 5mg IM haloperidol
Haloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM | 11 |
| Droperidol these patients will receive 2.5mg IV droperidol
Droperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV | 14 |
| Ondansetron these patients will receive 8mg IV ondansetron
Ondansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron | 7 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 9 | 6 |
Baseline characteristics
| Characteristic | Haloperidol | Droperidol | Ondansetron | Total |
|---|---|---|---|---|
| Age, Continuous | 32.45 years STANDARD_DEVIATION 8.56 | 29.93 years STANDARD_DEVIATION 9.52 | 27.57 years STANDARD_DEVIATION 9.52 | 30.28 years STANDARD_DEVIATION 10.29 |
| Nausea_Before_Medication | 3.4 units on a scale: 0 through 10 STANDARD_DEVIATION 3.37 | 3.69 units on a scale: 0 through 10 STANDARD_DEVIATION 2.5 | 5.00 units on a scale: 0 through 10 STANDARD_DEVIATION 4.1 | 3.86 units on a scale: 0 through 10 STANDARD_DEVIATION 3.11 |
| Pain_Before_Medication | 4.00 units on a scale: 0 through 10 STANDARD_DEVIATION 3.3 | 3.38 units on a scale: 0 through 10 STANDARD_DEVIATION 3.04 | 4.80 units on a scale: 0 through 10 STANDARD_DEVIATION 3.7 | 3.86 units on a scale: 0 through 10 STANDARD_DEVIATION 3.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 3 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 4 Participants | 15 Participants |
| Region of Enrollment United States | 11 participants | 14 participants | 7 participants | 32 participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 2 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 14 | 0 / 7 |
| other Total, other adverse events | 0 / 11 | 0 / 14 | 0 / 7 |
| serious Total, serious adverse events | 0 / 11 | 0 / 14 | 0 / 7 |
Outcome results
Primary
Abdominal Pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol | Abdominal Pain | 5 score on a scale | — |
| Droperidol | Abdominal Pain | 2.6 score on a scale | Standard Deviation 3.71 |
| Ondansetron | Abdominal Pain | 3 score on a scale | — |
Primary
Abdominal Pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol | Abdominal Pain | 4.00 score on a scale | Standard Deviation 3.3 |
| Droperidol | Abdominal Pain | 3.38 score on a scale | Standard Deviation 3.04 |
| Ondansetron | Abdominal Pain | 4.8 score on a scale | Standard Deviation 3.7 |
Primary
Abdominal Pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol | Abdominal Pain | 0 score on a scale | — |
| Droperidol | Abdominal Pain | 3.69 score on a scale | Standard Deviation 4.1 |
| Ondansetron | Abdominal Pain | 2 score on a scale | — |
Primary
Nausea
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol | Nausea | 3.0 score on a scale | — |
| Droperidol | Nausea | 3.0 score on a scale | Standard Deviation 3.67 |
| Ondansetron | Nausea | 7.0 score on a scale | — |
Primary
Nausea
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol | Nausea | 3.40 score on a scale | Standard Deviation 3.37 |
| Droperidol | Nausea | 3.69 score on a scale | Standard Deviation 2.5 |
| Ondansetron | Nausea | 5 score on a scale | Standard Deviation 4.1 |
Primary
Nausea
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Haloperidol | Nausea | 0.5 score on a scale | — |
| Droperidol | Nausea | 3.2 score on a scale | Standard Deviation 3.42 |
| Ondansetron | Nausea | 1 score on a scale | — |
Secondary
Treatment Success
both abdominal pain and nausea scores under 2 (none or minimal)
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Haloperidol | Treatment Success | 1 Participants |
| Droperidol | Treatment Success | 2 Participants |
| Ondansetron | Treatment Success | 1 Participants |
Secondary
Treatment Success
both abdominal pain and nausea scores under 2 (none or minimal)
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Haloperidol | Treatment Success | 0 Participants |
| Droperidol | Treatment Success | 3 Participants |
| Ondansetron | Treatment Success | 0 Participants |
Secondary
Treatment Success
both abdominal pain and nausea scores under 2 (none or minimal)
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Haloperidol | Treatment Success | 2 Participants |
| Droperidol | Treatment Success | 3 Participants |
| Ondansetron | Treatment Success | 1 Participants |