EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron
Condition: Nausea
MeSH terms: Nausea
Study type: Interventional

Summary: 
      Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment
      that is often treated with oral or intravenous anti-emetic medications. Research Design/Plan:
      This will be a randomized equivalence study comparing the reduction in a patient's reported
      level of nausea after treatment with either Ondansetron or IPA Methods: Patients who report
      nausea and/or vomiting in the normal evaluation and care of after calling 911 for Emergency
      Medical Care will be offered enrollment in the study. A short script will be attached to the
      outside of each study packet providing information about the study and its risks and
      benefits. Verbal or written (waiver of informed consent will be requested) permission will be
      obtained to start randomization. If the patient agrees to enroll then the study packet will
      be opened and utilized. All Advanced Life Support Ambulances in the San Antonio Fire
      Department will have sealed numbered opaque boxes or envelopes with either: 70% Isopropyl
      Alcohol swabs or ondansetron. Six Visual Nausea Severity Scoring cards will be provided with
      a marking pen to record timed nausea levels before and upon arrival to the Emergency
      Department and 15 minutes after treatment whichever comes first.

      Clinical Relevance: This treatment has not been studied in the unique environment encountered
      by Paramedics in the Pre-Hospital setting. If this treatment is found to be effective, it
      many offer a very simple, extremely inexpensive and non-invasive (basic life support)
      approach for the treatment of nausea.
    

Detailed description: 
      Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment
      that is often treated with oral or intravenous anti-emetic medications. Post operative
      patients with modern anesthesia techniques and processes still have a 20-30% incidence of
      Nausea and/or vomiting. Nausea is a complicated symptom that is though to arise from the
      vomiting center in the lateral reticular formation in the brainstem. Afferent inputs form the
      cerebellum, higher cortical centers, the vestibular apparatus, the glossopharyngeal nerve and
      the vagal nerve inputs contribute to the process of the perception of nausea. Chemoreceptors
      in the Chemoreceptor Trigger Zone (CTZ) are located on the brain surface and are highly
      vascularized leading to increased exposure to neurotransmitters such as Serotonin (5-HT-3),
      histamine (H1) acetylcholine and dopamine. Blocking such neurotransmitter stimulation with
      targeted medications such as antihistamines or 5-HT-3 antagonists such as Ondansetron.

      Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment
      that is often treated with oral or intravenous anti-emetic medications. Many patients do not
      respond well to this therapy, and EMS services that have only basic life support (BLS)
      capabilities may not have any good treatment currently. Additionally, because of the
      configuration of modern day ambulances, the patient is transport in a rear facing position in
      the patient compartment with very limited view of the environment. This method of transport
      frequently causes motion sickness.

      Motion sickness is thought to be caused by inadequate adaption of the body to conflicts
      between vestibular, visual, other proprioceptive inputs and inhibition of the vestibular
      cerebellum. Common therapies may include antihistamines, benzodiazepines, tricyclic
      antidepressants and or scopolamine. Behavioral strategies such a watching the true horizon,
      steering the vehicle, tilting head into turns and laying down with eyes closed have been
      shown to alleviate some symptoms of motion sickness. But these strategies are not available
      in the EMS environment. Scopolamine administered well before motion stimulus has been shown
      to prevent motion sickness and acute treatment is best when using sedating antihistamines.
      Non-sedating antihistamines, Ondansetron and ginger root have not been found to effectively
      prevent nor treat motion sickness.

      Multiple agents have been studied for the treatment of nausea in the emergency department
      with equivalency of effect and time on onset. Common agents include ondansetron,
      metoclopramide, promethazine and prochlorperazine. Such agents have also been used in the EMS
      environment to some degree, but require parenteral administration with exposure to the risks
      for side effects or sedation. There are also not options at the BLS level. Post-operative
      oxygen therapy has not been shown to decrease post nausea after c-section delivery which is
      disappointing as this is a ubiquitous therapy in the EMS environment of care, is inexpensive
      and easy to administer. Ondansetron has been shown to be safe and effective in the
      prehospital environment with a low incidence of side effects but cost and need for parenteral
      administration is often a barrier to care.

      Multiple studies have shown Isopropyl Alcohol (IPA) 70% aromatherapy to be as effective as
      Ondansetron with a more rapid onset of nausea relief. This therapy was performed by holding a
      folded saturated 70% IPA pad under the nares with the patient inhaling the vapors. The
      patient is simply instructed to take three deep breaths through their nose. In animal
      experiments, toxicity from inhalation of IPA is very low at doses allowable by inhalation as
      compared with dermal or oral ingestion. Dermal application of IPA is routinely used by EMS
      personnel to cleanse the area of skin immediately surrounding the insertion point of an
      intravascular catheter for medication administration, or blood draw.

      PURPOSE:

      IPA Therapy may offer a very inexpensive, easy to administer, and effective alternative to
      medication therapy for nausea and vomiting in the prehospital.

      RECRUITMENT AND RANDOMIZATION PROCESS Patients who report nausea and/or vomiting in the
      normal evaluation and care of after calling 911 for Emergency Medical Care will be offered
      enrollment in the study.

      A short script will be attached to the outside of each study packet providing information
      about the study and its risks and benefits. Verbal or written (waiver of informed consent
      will be requested) permission will be obtained to start randomization. If the patient agrees
      to enroll then the study packet will be opened and utilized.

      PROCEDURES AND LOGISTICS

      All Advanced Life Support Ambulances in the San Antonio Fire Department will have sealed
      numbered opaque boxes or envelopes with either:

        -  Three large 2 ply 70% Isopropyl Alcohol swabs OR

        -  Ondansetron (Zofran) 4mg for IV/IM use

      These study packets will have similar weight, shape and contour despite the contents. If
      needed, props may be includes to make packages similar in weight, contour or sound when
      shaken so as to not reveal its true contents. The goal is to enroll at least 400 patients
      over a 1 year period.

      For each arm, the package will contain a step by step instruction checklist. Six Visual
      Nausea Severity Scoring cards will be provided with a marking pen to record timed nausea
      levels before and upon arrival to the Emergency Department and 15 minutes after treatment
      whichever comes first. The treatment protocol for each arm will be:

      70% Isopropyl Alcohol

        1. Mark Time and Visual Nausea Severity Score 0-10

        2. Remove alcohol prep with gloved hand

        3. Place under nares of the patient

        4. Instruct the patient to take three separate deep inhalations of the Isopropyl vapors
           through their nose

        5. Record time of treatment on back of first Visual Nausea Severity Score card.

        6. Mark time and Subsequent Visual Nausea Severity Scores upon arrival to the Emergency
           Department at indicated time intervals.

        7. If patient still has significant nausea and or vomiting after ten minutes provide rescue
           Ondansetron therapy with 4mg of Ondansetron slow IV push or IM

        8. Mark time and Visual Nausea Severity Score upon arrival to the Emergency Department on
           third card.

        9. Document all interventions on electronic Patient Care record as per usual procedures.

       10. Complete Paramedic evaluation tool.

       11. Envelope or box, with Consent, score cards and Paramedic evaluation tool will be
           returned to Medic Officer on duty and a new study packet will be replaced.

       12. Used Study Packets will be collected by the Investigators

      Ondansetron 4mg IV/IM (standard of care)

        1. Mark Time and Visual Nausea Severity Score 0-10 on first enclosed card.

        2. Start IV if not already done so.

        3. If unable to obtain IV access in two attempts use intramuscular route.

        4. Inject 4mg of Ondansetron slow IV push or IM.

        5. Record time of treatment on back of first Visual Nausea Severity Score card.

        6. Mark time and Second Visual Nausea Severity Score upon arrival to the Emergency
           Department or 10 minutes after treatment whichever comes first.

        7. If patient still has significant nausea and or vomiting after ten minutes provide rescue
           an additional dose of Ondansetron therapy with 4mg of Ondansetron slow IV push or IM

        8. Mark time and Visual Nausea Severity Score upon arrival to the Emergency Department on
           third card.

        9. Document all interventions on electronic Patient Care record as per usual procedures.

       10. Complete Paramedic evaluation tool.

       11. Envelope or box, with Consent, score cards and Paramedic evaluation tool will be
           returned to Medic Officer on duty and a new study packet will be replaced.

       12. Used Study Packets will be collected by the Investigators.

      Data Analysis Plan:

      A secure excel spreadsheet tool will be used to abstract data from the research data
      collection documents and the EMS electronic patient care record. The patient will only be
      identified by the randomization number, incident number, age (if greater than 89 age will be
      indicated by <89 years), sex and date of service in the database and on all study packet
      materials. All relevant time intervals and Visual Nausea Severity Scores will be recorded for
      enrolled patients. Time to treatment will be compared between the two arms of the study as
      well as changes in Visual Nausea Severity Scores. Treatment failures requiring additional
      Ondansetron will be characterized. Paramedic will be asked to evaluate the treatment provided
      for ease of use, time needed to complete the treatment and their impression of effectiveness
      of the assigned treatment. T-test and confidence intervals will be utilized to determine
      statistical significance.
    

Intervention name(s): IPA; Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): IPA Aromatherapy for the experimental arm; Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel.
Other intervention name(s): rubbing alcohol; Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment