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Aromatherapy for Postoperative Nausea and Vomiting in Children

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aromatherapy inhaler
Saline inhaler
Sponsored by
Stuart Wright
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Aromatherapy

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I or II
  • absence of neurodevelopment disorders
  • patient having elective day surgery

Exclusion Criteria:

  • family or patient refusal
  • allergy or sensitivity to aromatherapy oils
  • inability to smell in the postoperative period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aromatherapy

    Placebo

    Arm Description

    Aromatherapy inhaler (QueaseEASE, Soothing Scents Inc, Enterprise, AL) applied to nauseous post surgical paediatric patients in the postanesthetic care unit

    Saline inhaler applied to nauseous post surgical paediatric patients in the postanesthetic care unit

    Outcomes

    Primary Outcome Measures

    Reduction in postoperative nausea and vomiting score
    A validated nausea scale called the Baxter Animated Retching Faces (BARF) scale will be administered to the patient in the postanesthetic care unit. Upon arrival in the postanesthesia care unit the research assistant will assess for nausea using the BARF scale at 15-minute intervals. If the patient reports a BARF scale of 4 or greater, they will be entered into the study and randomized to a placebo or aromatherapy inhaler. The primary outcome is defined as a two-point reduction in the BARF scale. This has been shown to be a clinically significant effect in the paediatric nausea literature.

    Secondary Outcome Measures

    Total number of patients who used antiemetics
    The use of antiemetic by patients enrolled in the study at any time in the 2 hour post-operative period will be recorded as yes or no and expressed as the number of patients who needed antiemetics compared to the total number of patients in the intervention arm.
    Total number of patients with emesis
    The total number of patients who vomit in the 2 hour post-operative period.
    Total number of patients who continue to use the inhaler
    Total number of patients who continue use of the study inhaler post first dose of aromatherapy or placebo.
    Reduction in Baxter Animated Retching Faces (BARF) scale magnitude
    Patients enrolled in the study in the postanesthetic recovery unit will be administered the BARF scale post-intervention with the placebo or aromatherapy inhaler. The magnitude of the reduction in the BARF scale will be recorded for each subject. The net reduction number in the BARF scale will be averaged and expressed as the number with confidence intervals for each intervention.

    Full Information

    First Posted
    December 23, 2015
    Last Updated
    January 25, 2016
    Sponsor
    Stuart Wright
    Collaborators
    Soothing Scents, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02663154
    Brief Title
    Aromatherapy for Postoperative Nausea and Vomiting in Children
    Official Title
    Aromatherapy for Postoperative Nausea and Vomiting in Children: A Single Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Stuart Wright
    Collaborators
    Soothing Scents, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting
    Keywords
    Aromatherapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aromatherapy
    Arm Type
    Experimental
    Arm Description
    Aromatherapy inhaler (QueaseEASE, Soothing Scents Inc, Enterprise, AL) applied to nauseous post surgical paediatric patients in the postanesthetic care unit
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Saline inhaler applied to nauseous post surgical paediatric patients in the postanesthetic care unit
    Intervention Type
    Drug
    Intervention Name(s)
    Aromatherapy inhaler
    Other Intervention Name(s)
    QueaseEASE (Soothing Scents, Inc, Enterprise, AL)
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Saline inhaler
    Other Intervention Name(s)
    Placebo
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Reduction in postoperative nausea and vomiting score
    Description
    A validated nausea scale called the Baxter Animated Retching Faces (BARF) scale will be administered to the patient in the postanesthetic care unit. Upon arrival in the postanesthesia care unit the research assistant will assess for nausea using the BARF scale at 15-minute intervals. If the patient reports a BARF scale of 4 or greater, they will be entered into the study and randomized to a placebo or aromatherapy inhaler. The primary outcome is defined as a two-point reduction in the BARF scale. This has been shown to be a clinically significant effect in the paediatric nausea literature.
    Time Frame
    2 hours postoperative in the post anesthetic care unit
    Secondary Outcome Measure Information:
    Title
    Total number of patients who used antiemetics
    Description
    The use of antiemetic by patients enrolled in the study at any time in the 2 hour post-operative period will be recorded as yes or no and expressed as the number of patients who needed antiemetics compared to the total number of patients in the intervention arm.
    Time Frame
    2 hours post-operatively
    Title
    Total number of patients with emesis
    Description
    The total number of patients who vomit in the 2 hour post-operative period.
    Time Frame
    2 hours post-operatively
    Title
    Total number of patients who continue to use the inhaler
    Description
    Total number of patients who continue use of the study inhaler post first dose of aromatherapy or placebo.
    Time Frame
    2 hours post-operatively
    Title
    Reduction in Baxter Animated Retching Faces (BARF) scale magnitude
    Description
    Patients enrolled in the study in the postanesthetic recovery unit will be administered the BARF scale post-intervention with the placebo or aromatherapy inhaler. The magnitude of the reduction in the BARF scale will be recorded for each subject. The net reduction number in the BARF scale will be averaged and expressed as the number with confidence intervals for each intervention.
    Time Frame
    2 hours post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) class I or II absence of neurodevelopment disorders patient having elective day surgery Exclusion Criteria: family or patient refusal allergy or sensitivity to aromatherapy oils inability to smell in the postoperative period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stuart Wright, MD
    Organizational Affiliation
    IWK Health Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27829428
    Citation
    Kiberd MB, Clarke SK, Chorney J, d'Eon B, Wright S. Aromatherapy for the treatment of PONV in children: a pilot RCT. BMC Complement Altern Med. 2016 Nov 9;16(1):450. doi: 10.1186/s12906-016-1441-1.
    Results Reference
    derived

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    Aromatherapy for Postoperative Nausea and Vomiting in Children

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