Aromatherapy for Postoperative Nausea and Vomiting in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02663154|
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : January 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: Aromatherapy inhaler Drug: Saline inhaler||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Aromatherapy for Postoperative Nausea and Vomiting in Children: A Single Blind Randomized Clinical Trial|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||July 2015|
Aromatherapy inhaler (QueaseEASE, Soothing Scents Inc, Enterprise, AL) applied to nauseous post surgical paediatric patients in the postanesthetic care unit
Drug: Aromatherapy inhaler
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
Other Name: QueaseEASE (Soothing Scents, Inc, Enterprise, AL)
Placebo Comparator: Placebo
Saline inhaler applied to nauseous post surgical paediatric patients in the postanesthetic care unit
Drug: Saline inhaler
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 Name: Placebo
- Reduction in postoperative nausea and vomiting score [ Time Frame: 2 hours postoperative in the post anesthetic care unit ]
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.
- Total number of patients who used antiemetics [ Time Frame: 2 hours post-operatively ]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 [ Time Frame: 2 hours post-operatively ]The total number of patients who vomit in the 2 hour post-operative period.
- Total number of patients who continue to use the inhaler [ Time Frame: 2 hours post-operatively ]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 [ Time Frame: 2 hours post-operatively ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663154
|Principal Investigator:||Stuart Wright, MD||IWK Health Centre|