NauseaNCT02092441
Inhalation Intervention for Nausea in the Emergency Department
A study testing Alcohol prep pad group and Normal Saline prep pad in people with Nausea and Vomiting, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Alcohol prep pad group and Normal Saline prep pad
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emergency Department, Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients.
Read the 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.
- Being tested
- Alcohol prep pad group, Normal Saline prep pad
- Keywords
- Nausea, Vomiting, Antiemetic
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol prep pad groupOther
Subjects inhale scent of alcohol pad
Normal Saline prep padOther
Subjects inhale scent of placebo (normal saline) pads
| Study group | Role | What they receive |
|---|---|---|
| Alcohol prep pad group | Active comparator | isopropyl alcohol prep pad Receives: Other: Alcohol prep pad group |
| Normal Saline prep pad | Placebo comparator | normal saline prep pad Receives: Other: Normal Saline prep pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes post intervention
Secondary outcomes (1)
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention
Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable")
Measured: 10 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael D. April, Brooke Army Medical Center
- Investigators
- Kenneth L Beadle, MPAS, BS, Principal investigator, BAMCCurtis J Hunter, M.D., Study director, BAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092441
- Sponsor's protocol ID
- BAMC 395266-1
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2014
- Last updated
- 23 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 7835543Gill 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.
PubMed 7782562Burleigh-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.
PubMed 9143479Cotton 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.
PubMed 17304779Winston 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.
PubMed 12776641Pellegrini 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.
PubMed 19731848Wang 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.
PubMed 10434220Beadle 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.
PubMed 26679977
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation Intervention for Nausea in the Emergency Department
- ClinicalTrials.gov ID
- NCT02092441
- Acronym / sponsor ID
- BAMC 395266-1
- Keywords
- Nausea, Vomiting, Antiemetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 31 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol prep pad group | Active comparator | Other: Alcohol prep pad groupisopropyl alcohol prep pad |
| Normal Saline prep pad | Placebo comparator | Other: Normal Saline prep padnormal saline prep pad |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol prep pad groupSubjects inhale scent of alcohol pad | Other | Alcohol prep pad group |
| Normal Saline prep padSubjects inhale scent of placebo (normal saline) pads | Other | Normal Saline prep pad |
Primary outcome
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention
Time frame: 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.
1 secondary outcome
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention
Time frame: 10 minutes post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7835543Burleigh-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.
- Background: PubMed 7782562Gill 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.
- Background: PubMed 9143479Burleigh-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.
- Background: PubMed 17304779Cotton 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.
- Background: PubMed 12776641Winston 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.
- Background: PubMed 19731848Pellegrini 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.
- Background: PubMed 10434220Wang 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.
- Derived from this study: PubMed 26679977Beadle 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.
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth L Beadle, MPAS, BS principal investigator
BAMC
Curtis J Hunter, M.D. study director
BAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol prep pad group and Normal Saline prep pad in people with Nausea and Vomiting, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention (time frame: 10 minutes post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092441, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.