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Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol prep pad group | Active Comparator | isopropyl alcohol prep pad |
|
| Normal Saline prep pad | Placebo Comparator | normal saline prep pad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol prep pad group | Other | Subjects inhale scent of alcohol pad |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention | Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable") | 10 minutes post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | 10 minutes post intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth L Beadle, MPAS, BS | BAMC | Principal Investigator |
| Curtis J Hunter, M.D. | BAMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7835543 | Background | Burleigh-Flayer HD, Gill MW, Strother DE, Masten LW, McKee RH, Tyler TR, Gardiner T. Isopropanol 13-week vapor inhalation study in rats and mice with neurotoxicity evaluation in rats. Fundam Appl Toxicol. 1994 Oct;23(3):421-8. doi: 10.1006/faat.1994.1123. | |
| 7782562 | Background | Gill MW, Burleigh-Flayer HD, Strother DE, Masten LW, McKee RH, Tyler TR, Gardiner TH. Isopropanol: acute vapor inhalation neurotoxicity study in rats. J Appl Toxicol. 1995 Mar-Apr;15(2):77-84. doi: 10.1002/jat.2550150204. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol Prep Pad Group | isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad |
| FG001 | Normal Saline Prep Pad | normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol Prep Pad Group | isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad |
| BG001 | Normal Saline Prep Pad | normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | VNRS | 10 minutes post intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol Prep Pad Group | isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D. April | Brooke Army Medical Center | 210-916-6129 | Michael.D.April@post.harvard.edu |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Normal Saline prep pad |
| Other |
Subjects inhale scent of placebo (normal saline) pads |
|
| 9143479 | Background | Burleigh-Flayer H, Garman R, Neptun D, Bevan C, Gardiner T, Kapp R, Tyler T, Wright G. Isopropanol vapor inhalation oncogenicity study in Fischer 344 rats and CD-1 mice. Fundam Appl Toxicol. 1997 Apr;36(2):95-111. doi: 10.1006/faat.1996.2284. |
| 17304779 | Background | Cotton JW, Rowell LR, Hood RR, Pellegrini JE. A comparative analysis of isopropyl alcohol and ondansetron in the treatment of postoperative nausea and vomiting from the hospital setting to the home. AANA J. 2007 Feb;75(1):21-6. |
| 12776641 | Background | Winston AW, Rinehart RS, Riley GP, Vacchiano CA, Pellegrini JE. Comparison of inhaled isopropyl alcohol and intravenous ondansetron for treatment of postoperative nausea. AANA J. 2003 Apr;71(2):127-32. |
| 19731848 | Background | Pellegrini J, DeLoge J, Bennett J, Kelly J. Comparison of inhalation of isopropyl alcohol vs promethazine in the treatment of postoperative nausea and vomiting (PONV) in patients identified as at high risk for developing PONV. AANA J. 2009 Aug;77(4):293-9. |
| 10434220 | Background | Wang SM, Hofstadter MB, Kain ZN. An alternative method to alleviate postoperative nausea and vomiting in children. J Clin Anesth. 1999 May;11(3):231-4. doi: 10.1016/s0952-8180(99)00035-5. |
| 26679977 | Derived | Beadle KL, Helbling AR, Love SL, April MD, Hunter CJ. Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):1-9.e1. doi: 10.1016/j.annemergmed.2015.09.031. Epub 2015 Dec 8. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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") | Posted | Median | Inter-Quartile Range | VNRS | 10 minutes post intervention |
|
|
|
| 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") | Posted | Median | Inter-Quartile Range | 5 point Likert Scale | 10 minutes post intervention |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Normal Saline Prep Pad | normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads | 0 | 43 | 0 | 43 |
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