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
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Aromatherapy
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
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
NCT ID
NCT02663154
First Posted
December 23, 2015
Last Updated
January 25, 2016
Sponsor
Stuart Wright
Collaborators
Soothing Scents, Inc.
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
Learn more about this trial
Aromatherapy for Postoperative Nausea and Vomiting in Children
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