Clinical trial NCT02663154: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: Aromatherapy
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Soothing Scents, Inc.
First posted: 2016-01-26
Enrollment: 39
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reduction in postoperative nausea and vomiting score
timeFrame: 2 hours postoperative in the post anesthetic care unit
Secondary outcomes:
measure: Total number of patients who used antiemetics
timeFrame: 2 hours post-operatively
measure: Total number of patients with emesis
timeFrame: 2 hours post-operatively
measure: Total number of patients who continue to use the inhaler
timeFrame: 2 hours post-operatively
measure: Reduction in Baxter Animated Retching Faces (BARF) scale magnitude
timeFrame: 2 hours post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Stuart Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.