ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001327572

Ethics application status

Approved

Date submitted

2/12/2015

Date registered

3/12/2015

Date last updated

30/09/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Chewing Gum for the Treatment of Post-Operative Nausea and Vomiting

Scientific title

Pilot trial: Efficacy of chewing gum for the treatment of post-operative nausea and vomiting in females undergoing laparoscopic or breast surgery

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1177-1892

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post operative nausea and vomiting

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Wrigley's Peppermint flavoured gum, administered in the Post Anaesthesia Care Unit in the event of nausea or vomiting occurring after anaesthesia. Gum chewing period is one stick of gum, chewed for target 15 minutes, not repeated in the event of repeat nausea or vomiting. Adherence will be monitored via researcher at the bedside.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Ondansetron 4mg intravenous to control group, in a single dose, in the event of nausea and vomiting complained of. Administered by recovery room nurse, monitored and recorded by study staff in the drug administration log.

Control group

Active

Outcomes

Primary outcome [1]

Efficacy of chewing gum as a rescue therapy for PONV, determined by complete resolution of symptoms as reported by patient.

Timepoint [1]

15 minutes after intervention concluded.

Secondary outcome [1]

Incidence of nausea, retching or vomiting in PACU, reported by patient and monitored by study staff, recorded in study log.

Timepoint [1]

At any point during PACU admission

Secondary outcome [2]

Patient satisfaction with anti-emetic treatment, assessed with 5 point Likert scale

Timepoint [2]

At discharge from PACU

Eligibility

Key inclusion criteria

Female patients aged 18 years and over
American Society of Anesthesiologists’ (ASA) physical status 1-3
Laparoscopic or breast surgery (wide local excision/mastectomy)

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
Significant cardiorespiratory impairment (i.e. ASA 4 patients)
Impaired pharyngeal/oesophageal function (e.g. bulbar palsy, achalasia)
Phenylketonuria (contraindication to sweetener aspartame in chewing gum)
Contraindication to dexamethasone (e.g. severe uncontrolled diabetes mellitus, uncontrolled infection)
Contraindication to droperidol (e.g. prolonged QT syndrome)
Contraindication to ondansetron
Full upper or lower denture (not feasible to chew gum)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Concealed envelope technique

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomisation sequence

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Continuous data will be tested for normality. Normally distributed data will be summarised using mean and standard deviation and will be compared with unpaired two-tailed t-tests. Non-normally distributed data will be summarized with median (range/IQR) and will be compared with Wilcoxon ranksum tests. Categorical data will be summarised using number (count) and compared using Fischer’s exact test or chi-squared test as appropriate. Survival data (e.g. time to discharge) will be summarised using median (range/IQR) and compared using the logrank test.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

8/02/2016

Actual

5/02/2016

Date of last participant enrolment

Anticipated

8/08/2016

Actual

23/06/2016

Date of last data collection

Anticipated

Actual

23/06/2016

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Royal Melbourne Hospital

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

630 St Kilda Rd., Melbourne VIC 3004

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Individual

Name [1]

Professor Kate Leslie

Address [1]

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health HREC

Ethics committee address [1]

Office for Research
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/10/2015

Approval date [1]

21/12/2015

Ethics approval number [1]

Summary

Brief summary

The aim of this pilot trial is to determine the efficacy and safety of chewing gum compared with ondansetron for the treatment of postoperative nausea or vomiting (PONV). PONV is a significant complication of general anaesthesia. In addition to patient dissatisfaction resulting from PONV, the cost burdens of anti-emetic therapy and delayed discharge from the PACU are considerable. Chewing gum in the postoperative period has been well established in the treatment of ileus resulting from gastrointestinal surgery, but its efficacy as a treatment for PONV has to date not been assessed. A prospective cohort study conducted by this research team on the use of chewing gum in the PACU confirmed its acceptability to patients and staff. We now propose to determine the non-inferiority of chewing gum to ondansetron for PONV. The results of this pilot study will guide a future large randomised controlled trial assessing the efficacy of this comparative simple therapy, of negligible cost. This study thus has the potential to significantly improve patient and health service outcomes.

The aims of the pilot study
1. Refine and test the trial protocol for a large multicentre study
2. Assess acceptability of the trial protocol to our patients and anaesthetic/nursing staff, as a
high recruitment and participation rate will be required for a viable definitive study.
3. Confirm the high rates of PONV despite prophylaxis seen in our prior trial, to inform sample
size estimates for a definitive trial.
4. Assess the proportion of patients meeting criteria for chewing gum in the PACU, to guide the external validity of this trial.
5. Assess the event rates using the protocol developed

Hypothesis to be tested
Chewing gum in the immediate postoperative period is efficacious and safe compared to ondansetron in the treatment of PONV.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 3 9342 7136

Fax

jai.darvall@mh.org.au

Contact person for public queries

Name

Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 3 9342 7136

Fax

jai.darvall@mh.org.au

Contact person for scientific queries

Name

Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 3 9342 7136

Fax

jai.darvall@mh.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Chewing gum for the treatment of postoperative nausea and vomiting: A pilot randomized controlled trial.	2017	https://dx.doi.org/10.1093/bja/aew375

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically