Aromatherapy for Postoperative Nausea and Vomiting in Children

NCT ID: NCT02663154

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Aromatherapy

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

Group Type: EXPERIMENTAL

Aromatherapy inhaler

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline inhaler

Intervention Type: DRUG

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)

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

QueaseEASE (Soothing Scents, Inc, Enterprise, AL); Placebo

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soothing Scents, Inc.

INDUSTRY

Sponsor Role: collaborator

Stuart Wright

OTHER

Sponsor Role: lead

Responsible Party

Stuart Wright

Assistant Professor, Dept of Pediatric Anesthesia, IWK Health Centre

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stuart Wright, MD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

References

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.

Reference Type: DERIVED

PMID: 27829428 (View on PubMed)

Other Identifiers

1016941

Identifier Type: -

Identifier Source: org_study_id