Aromatherapy for Postoperative Nausea and Vomiting in Children

NCT02663154 | Completed Phase 2

• 1 other identifier: 1016941
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Aromatherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours postoperative in the post anesthetic care unit

Secondary Outcomes (4)

• Total number of patients who used antiemetics

  2 hours post-operatively

• Total number of patients with emesis

  2 hours post-operatively

• Total number of patients who continue to use the inhaler

  2 hours post-operatively

• Reduction in Baxter Animated Retching Faces (BARF) scale magnitude

  2 hours post-operatively

Study Arms (2)

Aromatherapy

EXPERIMENTAL

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

Drug: Aromatherapy inhaler

Placebo

PLACEBO COMPARATOR

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

Drug: Saline inhaler

Interventions

Aromatherapy inhaler 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

Also known as: QueaseEASE (Soothing Scents, Inc, Enterprise, AL)

Aromatherapy

Saline inhaler 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)

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stuart Wright: lead
• Soothing Scents, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 27829428 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Stuart Wright, MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Dept of Pediatric Anesthesia, IWK Health Centre

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 26, 2016
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01