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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] 288055 0
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 296918 0
Condition category
Condition code
Anaesthesiology 297156 297156 0 0
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] 293374 0
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] 296770 0
Efficacy of chewing gum as a rescue therapy for PONV, determined by complete resolution of symptoms as reported by patient.
Timepoint [1] 296770 0
15 minutes after intervention concluded.
Secondary outcome [1] 319296 0
Incidence of nausea, retching or vomiting in PACU, reported by patient and monitored by study staff, recorded in study log.
Timepoint [1] 319296 0
At any point during PACU admission
Secondary outcome [2] 319297 0
Patient satisfaction with anti-emetic treatment, assessed with 5 point Likert scale
Timepoint [2] 319297 0
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?
No
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
94
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4834 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 12339 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 292490 0
Other
Name [1] 292490 0
Australian and New Zealand College of Anaesthetists
Country [1] 292490 0
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] 291202 0
None
Name [1] 291202 0
None
Address [1] 291202 0
None
Country [1] 291202 0
Other collaborator category [1] 278718 0
Individual
Name [1] 278718 0
Professor Kate Leslie
Address [1] 278718 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country [1] 278718 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293957 0
Melbourne Health HREC
Ethics committee address [1] 293957 0
Office for Research
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Ethics committee country [1] 293957 0
Australia
Date submitted for ethics approval [1] 293957 0
28/10/2015
Approval date [1] 293957 0
21/12/2015
Ethics approval number [1] 293957 0

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 61938 0
Dr Jai Darvall
Address 61938 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 61938 0
Australia
Phone 61938 0
+61 3 9342 7136
Fax 61938 0
Email 61938 0
[email protected]
Contact person for public queries
Name 61939 0
Dr Jai Darvall
Address 61939 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 61939 0
Australia
Phone 61939 0
+61 3 9342 7136
Fax 61939 0
Email 61939 0
[email protected]
Contact person for scientific queries
Name 61940 0
Dr Jai Darvall
Address 61940 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 61940 0
Australia
Phone 61940 0
+61 3 9342 7136
Fax 61940 0
Email 61940 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseChewing gum for the treatment of postoperative nausea and vomiting: A pilot randomized controlled trial.2017https://dx.doi.org/10.1093/bja/aew375
N.B. These documents automatically identified may not have been verified by the study sponsor.