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April MD, Oliver JJ, Davis WT, Ong D, Simon EM, Ng PC, Hunter CJ. Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):184-193. PubMed
P |
Adults in the Emergency Department |
I |
Inhaled Isopropyl Alcohol (IPA) |
C |
Oral ondansetron |
O |
Treatment of undifferentiated nausea and vomiting |
T |
30 minutes |
Level of Evidence: |
2 |
Study Design: |
Double blind, Randomized, Placebo-Controlled Trial - (DB-RCT) |
Population: |
Adults in the Emergency Department
|
Inclusion Criteria: |
Ages 18 to 65 with a chief complaint of nausea and vomiting and a Visual Analog Scale (VAS) score >3 |
Exclusion Criteria: |
- Known allergy to isopropyl alcohol or ondansetronI
- Inability to inhale through the nares (e.g., rhinitis)
- Recent intake of medications contraindicating alcohol administration, including cefoperazone, disulfiram, or metronidazole; altered mental status precluding signed informed consent
- A known history of QT-segment prolongation
- Clinical suspicion for serotonin syndrome
- Treating provider discretion
|
Interventions: |
- Inhaled IPA + PO Placebo
- Inhaled Placebo + PO Ondansetron
- Inhaled IPA + PO Ondansetron
|
Other Treatments: |
Continued ED management |
Follow-up or Duration: |
VAS score at 60 min |
Primary Endpoint: |
Change in VAS from baseline at 30 minutes |
Secondary Endpoint(s): |
Nausea scores until ED disposition, pain score at ED disposition, satisfaction VAS scores, administration of rescue antiemetic medications during ED stay, ED length of stay |
Results: |
Reduction in VAS at 30 min (0-100):
- IPA +Ondansetron = 30 (SD 27)
- IPA + Placebo = 32 (SD 23)
- Placebo + Ondansetron = 9 (SD 16)
|
Abstract Conclusions: |
Among ED patients with acute nausea who do not require immediate intravenous access, aromatherapy with or without oral ondansetron provides greater nausea relief than oral ondansetron alone.
|
Location(s): |
Department of Emergency Medicine, San Antonio Uniformed Services Health Education Consortium, San Antonio, TX |
ClinicalTrials.gov |
NCT02760069 |
Level of Evidence |
2 |
Criteria Used |
OCEBM Levels of Evidence Working Group. "The Oxford Levels of Evidence 2". OCEBM
|
From Dr. Montoya:
- Most convincing research I have seen on this topic given the use of not only aromatherapy by itself but in addition to a commonly used antiemetic.
- Also, the prolonged time frame for primary outcome provided further evidence for IPA use.
- Some limitations are with only comparing IPA to one antiemetic along with the bias that naturally comes with IPA compared to NS. Further work could have been done to minimize this by using a scented placebo.
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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. PubMed
P |
Adult Emergency Department Patients |
I |
Inhaled Isopropyl Alcohol |
C |
Inhaled Normal Saline |
O |
Treatment of nausea and vomiting |
T |
10 minutes |
S |
Emergency Department |
Study Design: |
Double Blinded - RCT |
Sample Size: |
N = 84 eligible
N = 4 excluded
N = 80 included:
- N = 37 Inhaled Isopropyl Alcohol (IPA)
- N = 43 placebo (inhaled Normal Saline; INS)
|
Population: |
Emergency Department |
Inclusion Criteria: |
- 18 to 65 years of age with a chief complaint of nausea and vomiting
- VAS Scores >3
|
Exclusion Criteria: |
- Known allergy to isopropyl alcohol, inability to inhale through the nares (including recent upper respiratory infection)
- Inability to read or write in English, altered mental status (including intoxication)
- Antiemetic use within 24hrs (including nasally inhaled isopropyl alcohol) or psychoactive drug or a medication known to potentially produce nausea when exposed to alcohol (e.g., disulfiram, metronidazole, cefoperazone).
|
Groups & Interventions: |
- Inhaled IPA (n = 37)
- Inhaled normal saline (n = 43)
|
Other Treatments: |
Continued ED management |
Follow-up or Duration: |
VAS score at 10 minutes |
Primary Endpoint: |
Reduction in nausea at 10 minutes |
Secondary Endpoint: |
Patient satisfaction and pain reduction at 10 minutes |
Results: |
- Mean VAS score at 10 minutes (0-10): IPA = 3, INS = 6, Effect size = 3 (CI 2 to 4)
- Patient Pain Reduction VNRS at 10 minutes (0-10): IPA=6, INS=6, Effect size=0 (CI -1 to 2)
- Patient Satisfaction (1-5): IPA 4, INS = 2, Effect size = 2 (CI 2 to 2)
|
Abstract Conclusions: |
Inhaled isopropyl alcohol achieves increased nausea relief compared with placebo during a 10-minute period. |
Location: |
Department of Emergency Medicine, San Antonio Uniformed Services Health Education Consortium, San Antonio, TX |
ClinicalTrials.gov |
NCT02092441 |
Level of Evidence: |
2 |
Criteria: |
OCEBM Levels of Evidence Working Group. "The Oxford Levels of Evidence 2". OCEBM
|
From Dr. Montoya:
- Effective first trial displaying IPA as a possible treatment for N/V in adult ED patients.
- A wide range of suspected pathologies of N/V were included in the patient population allowing for the generalizability of IPA use for undifferentiated patients.
- The short time frame to the primary outcome leads to questions about the long-term effectiveness of IPA for N/V.
- Similar to other studies, the question of bias from not using another placebo with a distinctive scent for the purpose of blinding patients and researchers exists.
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Candemir H, Akoglu H, Sanri E, Onur O, Denizbasi A. Isopropyl alcohol nasal inhalation for nausea in the triage of an adult emergency department. Am J Emerg Med. 2021 Mar;41:9-13. PubMed
P |
Adult Patients in the Emergency Department |
I |
Inhaled Isopropyl Alcohol (IPA) |
C |
Inhaled Normal Saline (INS) |
O |
Treatment of nausea and vomiting |
T |
10 minutes |
S |
Emergency Department |
Study Design: |
Double Blinded - RCT |
Sample Size: |
N = 118 eligible
N = 118 enrolled
N = 115 completed:
- N = 62 IPA (1 left)
- N = 56 Placebo (INS; 2 left)
|
Population: |
Adults in the Emergency Department with nausea and vomiting |
Inclusion Criteria: |
- Presenting with N/V
- Age 18-65 years of age
- ESI triage 4 or 5
- VAS score of 3 or above
|
Exclusion Criteria: |
- Pregnant
- Allergy or prior reaction to any inhalation agent
- No use of any antiemetics, psychoactive drugs, or medications known to reduce N&V in the last 6 hours
- Inability to complete the inhalation procedure
|
Groups & Interventions: |
- Inhaled IPA (n = 62)
- Inhaled Normal Saline (n = 56)
|
Other Treatments: |
None |
Follow-up or Duration: |
NRS scores at 10 minutes |
Primary Endpoint: |
Change in NRS values at 10 minutes |
Secondary Endpoint: |
Rescue treatment |
Results: |
- NRS (0-10) at10 minutes: IPA = 3.7 (CI 3-4.4), NS = 5.6 (CI 48-6.4)
- Rescue treatment: IPA = 27, NS = 40
|
Abstract Conclusion: |
IPA was significantly more effective than NS at treating N/V at triage |
Location: |
Department of Emergency Medicine, University of Health Sciences Sancaktepe Education and Research Hospital, Istanbul Turkey |
Level of Evidence: |
2 |
Criteria: |
OCEBM Levels of Evidence Working Group. "The Oxford Levels of Evidence 2". OCEBM
|
From Dr. Montoya:
- Overall promising study showing the effectiveness of IPA in treating N/V in adult ED patients. With that said, the researchers only evaluated ESI 4-5 patients leading to the question of is IPA effective for more critically ill patients with N/V.
- There is concern for bias given IPA has a distinctive scent compared to NS, which could have been more effectively blinded from both patient and administrator.
|