Aromatherapy for Postoperative Nausea and Vomiting in Children
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative nausea and vomiting (PONV) is one of the most common postoperative
      complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are
      approximately double those of adult patients. Aromatherapy has recently been shown to reduce
      PONV in adults, but the effect in paediatric patients is unknown. The goal of this study is
      to determine the feasibility of a large-scale study in the paediatric population.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is one of the most common postoperative
      complications of general anesthesia occurring after up to 40% of general anesthetics. PONV is
      an unpleasant experience and can result in secondary complications including wound
      dehiscence, electrolyte abnormalities and aspiration pneumonia. PONV often causes delayed
      stays in the postanesthesia care unit and delayed hospital discharge.

      The mechanism of PONV is poorly understood. Given the multifactorial nature of nausea and
      vomiting, standard pharmacological therapy approaches the problem from various pathways.
      Methods that include antihistaminic therapies such as dimenhydrinate (gravol),
      antiserotonergic medications such as ondansetron (Zofran) and glucocorticoids
      (dexamethasone), have been used effectively in different surgical settings to address PONV.
      They do not work however, without occasional significant side effects such as urinary
      retention, blurred vision, increased infection rates, headaches and constipation. Given that
      pharmacological interventions for PONV are not universally effective and have accompanying
      side effects, there has been recent interest in additional complementary interventions.

      Aromatherapy has been used to treat nausea from motion sickness, pregnancy, cancer and pain.
      In postoperative adults, a recent large adequately powered randomized control trial found
      aromatherapy resulted in a significant risk reduction of nausea (0.37) when compared with
      saline. Given the encouraging results of the first adequately powered adult study, the goal
      is to determine whether PONV is reduced by aromatherapy in the pediatric population. Thus,
      the primary aim of this study is to determine if aromatherapy is more effective than placebo
      in the treatment of postoperative nausea in children as a complementary treatment to current
      postoperative practices.

      This research is important as it is the first study to assesses whether aromatherapy can be
      useful in postoperative nausea treatment for children. The implications of this study could
      mean an improvement in the health care experience of children who have nausea postoperation
      and potentially a reduction in rescue antinausea drug use in this population in the future.
    

Intervention name(s): Aromatherapy inhaler; Saline inhaler
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation of commercial essential oil preparation (QueaseEASE) delivered in the commercial inhaler package in postanesthetic care unit after surgery in paediatric patients complaining of nausea; Inhaler is similar in design and function as the intervention inhaler only with saline rather than essential oils. Inhaler provided by the manufacturer QueaseEASE (Soothing Scents, Inc, Enterprise, AL)
Other intervention name(s): QueaseEASE (Soothing Scents, Inc, Enterprise, AL); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Aromatherapy