Nausea, Vomiting
Conditions
Keywords
Nausea, Vomiting, Antiemetic
Brief summary
Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients.
Detailed description
This study is to investigate if inhaling the scent of a typical medical alcohol prep pad will alleviate nausea as compared to a identically packaged normal saline prep pad for the Emergency Department patient with nausea. The study length will be 10 minutes long. The subjects will take several deep nasal inhalations at the 0, 2, 5 minute marks. Level of nausea will be recorded during these times and at 10 minutes. The investigators will also assess satisfaction of the intervention. As in previous post operative unit studies,the hypothesis is that there will a significant difference in levels of nausea between the alcohol pad group versus the normal saline pad group.
Interventions
OTHERAlcohol prep pad group
Subjects inhale scent of alcohol pad
OTHERNormal Saline prep pad
Subjects inhale scent of placebo (normal saline) pads
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age range of 18-65 years of age * complaint of nausea and or vomiting * ability to breathe through nose * ability to read and write English
Exclusion criteria
* allergy to isopropyl alcohol * pregnancy or pregnancy status unknown to subject. Pregnancy test only if part of clinical course. * recent upper respiratory infection * recent intake of cefoperazone, disulfiram, or metronidazole or any other medications that are known produce nausea when exposed to alcohol. * use of antiemetic or psychoactive drug within 24 hours * alcohol abuse * nicotine within last 4 hrs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention | 10 minutes post intervention | Primary outcome is nausea and vomiting measured on a scale from 0 (no nausea) to 10 (worst nausea imaginable) Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention | 10 minutes post intervention | Scale ranges from 0 (no pain) to 10 (worst pain imaginable) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Measured on a 5-point Likert Scale | 10 minutes post intervention | Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 (completely unsatisfied) to 5 (completely satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alcohol Prep Pad Group isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad | 37 |
| Normal Saline Prep Pad normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads | 43 |
| Total | 80 |
Baseline characteristics
| Characteristic | Alcohol Prep Pad Group | Normal Saline Prep Pad | Total |
|---|---|---|---|
| Age, Continuous | 35.65116 years STANDARD_DEVIATION 14.17557 | 31.94595 years STANDARD_DEVIATION 12.12652 | 33.9375 years STANDARD_DEVIATION 13.3154 |
| Sex: Female, Male Female | 23 Participants | 33 Participants | 56 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 43 |
| serious Total, serious adverse events | 0 / 37 | 0 / 43 |
Outcome results
Primary
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention
Primary outcome is nausea and vomiting measured on a scale from 0 (no nausea) to 10 (worst nausea imaginable) Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention.
Time frame: 10 minutes post intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcohol Prep Pad Group | Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention | 3 VNRS |
| Normal Saline Prep Pad | Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention | 6 VNRS |
Secondary
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention
Scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 10 minutes post intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcohol Prep Pad Group | Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention | 6 VNRS |
| Normal Saline Prep Pad | Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention | 6 VNRS |
Other Pre-specified
Satisfaction Measured on a 5-point Likert Scale
Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 (completely unsatisfied) to 5 (completely satisfied)
Time frame: 10 minutes post intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcohol Prep Pad Group | Satisfaction Measured on a 5-point Likert Scale | 4 5 point Likert Scale |
| Normal Saline Prep Pad | Satisfaction Measured on a 5-point Likert Scale | 2 5 point Likert Scale |