Phase 4
N=122
Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department
Nausea
Bottom Line
View on ClinicalTrials.gov: NCT02760069 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Nausea 100 mm Visual Analogue Scale (VAS) — 23; 19; 42 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Inhaled isopropyl alcohol (Drug); Oral ondansetron (Drug); Inhaled normal saline (Drug); Oral placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brooke Army Medical Center
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nausea 100 mm Visual Analogue Scale (VAS) |
23; 19; 42 | — |
| SECONDARY Number of Participants Who Required Rescue Anti-emetics |
11; 10; 18 | — |
Summary
This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.
Eligibility Criteria
Inclusion Criteria
- ages 18 and older
- complaint of nausea and/or vomiting reported at 3 or above on verbal numerical rating scale at the time of triage
Exclusion Criteria
- allergy to isopropyl alcohol or ondansetron
- inability to breathe through nose (e.g., recent upper respiratory infection)
- intake of cefoperazone, disulfiram, or metronidazole within the last 24 hours
- mental status precluding informed consent including intoxication
- known QT-prolongation
- clinical suspicion for serotonin syndrome
- intravenous catheter in place prior to study start
- medications administered since patient arrival (e.g., in triage)
Data sourced from ClinicalTrials.gov (NCT02760069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.