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Trial registered on ANZCTR


Registration number
ACTRN12619000928112
Ethics application status
Approved
Date submitted
5/06/2019
Date registered
3/07/2019
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of lidocaine preparations and their analgesic efficacy in epigastric pain
Scientific title
Comparison of lidocaine preparations and their analgesic efficacy in emergency room patients with epigastric pain
Secondary ID [1] 298426 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dyspepsia
313165 0
indigestion 313316 0
gastric pain 313317 0
Condition category
Condition code
Emergency medicine 311627 311627 0 0
Other emergency care
Anaesthesiology 311756 311756 0 0
Pain management
Oral and Gastrointestinal 311757 311757 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 ml of oral antacid (gastrogel: 500mg AlOH, MgSO3 240mg, MgOH24mg per 500ml) and 10 ml of lidocaine 2% viscous gel given as a one off oral dose together. These will be given as soon as the initial "pink lady" is prescribed by the treating clinician and the allocation has occurred

or

10 ml of oral antacid (gastrogel: 500mg AlOH, MgSO3 240mg, MgOH24mg per 500ml) and 10 ml of lidocaine 2% solution given as a one off oral dose together. These will be given as soon as the initial "pink lady" is prescribed by the treating clinician and the allocation has occurred

The randomly chosen arm is administered immediately and this equates to t=0 minutes The researchers are present from t=0 minutes to assess pain scores and platability. Although blinded to which arm is used they are able to ensure the intervention is given.

Please note, the "pink lady", as described in the protocol, is the term used for 10ml of antacid (gastrogel in the the current context) and 10m lidocaine viscous. It may also be known as a "pink mix"
Intervention code [1] 314677 0
Treatment: Drugs
Comparator / control treatment
20 ml of oral antacid (gastrogel: 500mg AlOH, MgSO3 240mg, MgOH24mg per 500ml) given as a one off oral dose . This will be given as soon as the initial "pink lady" is prescribed by the treating clinician and the allocation has occurred
Control group
Active

Outcomes
Primary outcome [1] 320322 0
analgesic efficacy in acute epigastric pain measured by change in visual analogue pain scale
Timepoint [1] 320322 0
60 minutes after the medication, a one-off dose, has been administered
Secondary outcome [1] 371249 0
analgesic efficacy in acute epigastric pain measured by change in visual analogue pain scale
Timepoint [1] 371249 0
30 minutes after the medication, a one-off dose, has been administered
Secondary outcome [2] 371250 0
Taste of the three solutions, using a visual analogue scale
Timepoint [2] 371250 0
60 minutes after the medication, a one-off dose, has been administered
Secondary outcome [3] 371601 0
Texture of the three solutions, using a visual analogue scale
Timepoint [3] 371601 0
60 minutes after the medication, a one-off dose, has been administered
Secondary outcome [4] 371602 0
Bitterness of the three solutions, using a visual analogue scale
Timepoint [4] 371602 0
60 minutes after the medication, a one-off dose, has been administered
Secondary outcome [5] 371603 0
Patient acceptability of the three solutions, using a visual analogue scale
Timepoint [5] 371603 0
60 minutes after the medication, a one-off dose, has been administered

Eligibility
Key inclusion criteria
• Adult patients 18 years and older.
• Patients presenting to the emergency department with acute epigastric pain who are prescribed an antacid / lidocaine mixture.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Refusal to participate
• Those who cannot communicate e.g. dementia, language barriers, or are too ill

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)
Allocation of a patient to the specific lidocaine preparation will be through randomised allocation. Pre-pared instructions for the analgesic mix will be prepared and block randomisation in groups of six will occur. Patients will be allocated the next set of blinded instructions once enrolled and consented. 30 and 60 minutes post administration, an investigator, blinded to which solution was given to the patient, will record the pain score of the patient, as well as the general acceptability of the solution, and subjective view on the pain relief, taste, texture and bitterness of the solution
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-pared instructions for the analgesic mix will be prepared and block randomisation in groups of six will occur. Patients will be allocated the next set of blinded instructions once enrolled and consented
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The change in pain score will be assessed using the Wilcoxon rank-sum test. Other variables will be assessed with t-tests if normally distributed or the Wilcoxon rank-sum test for non-parametric tests. Proportions will be assessed with chi-square tests

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13938 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 26708 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 302979 0
Hospital
Name [1] 302979 0
Royal Melbourne Hospital
Address [1] 302979 0
300 Grattan st Parkville, Victoria 3050
Country [1] 302979 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan St Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 302934 0
None
Name [1] 302934 0
Address [1] 302934 0
Country [1] 302934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303529 0
Melbourne Health Research Ethics Committee
Ethics committee address [1] 303529 0
300 Grattan St
Parkville, Victoria 3050
Ethics committee country [1] 303529 0
Australia
Date submitted for ethics approval [1] 303529 0
14/01/2019
Approval date [1] 303529 0
22/05/2019
Ethics approval number [1] 303529 0
HREC/46693/MH-2018

Summary
Brief summary
Background
Management of dyspepsia in Australian Emergency Departments (ED) typically includes lidocaine viscous and an antacid (pink lady or pink mix). We will investigate whether the addition of either lidocaine viscous or lidocaine solution improves analgesic efficacy, compared to an antacid monotherapy.

Methods
A double-blind randomised controlled trial will be undertaken in the ED of the Royal Melbourne Hospital, 7 days a week from 0800 to 2300. Patients prescribed a pink lady by the treating clinician and meeting inclusion criteria will be invited to participate. Patients will be randomly allocated one of three solutions. Option 1: 10mL oral lidocaine 2% viscous plus 10mL Gastrogel, option 2: 10mL lidocaine solution 2% plus 10mL Gastrogel, option 3: 20mL Gastrogel. Patient and investigator will be blinded to the medication given, and a pain score taken at t = 0, 30 and 60 minutes. The primary outcome will be the change in pain on a visual analogue scale at 60 minutes. Secondary outcomes include the change in pain scores at 30 minutes and an evaluation of taste, bitterness, texture and overall acceptability score using visual analogue scores. Proportions will be tested for significance using the chi-square test. Continuous variables are assumed to be non-parametric and will be tested using the Kruskal-Wallis test for difference in populations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93978 0
A/Prof Jonathan Knott
Address 93978 0
Royal Melbourne Hospital
300 Grattan St Parkville, VIC, 3050
Country 93978 0
Australia
Phone 93978 0
+61 3 93427009
Fax 93978 0
Email 93978 0
jonathan.knott@mh.org.au
Contact person for public queries
Name 93979 0
A/Prof Jonathan Knott
Address 93979 0
Royal Melbourne Hospital
300 Grattan St Parkville, Vic, 3050
Country 93979 0
Australia
Phone 93979 0
+61 3 93427000
Fax 93979 0
Email 93979 0
jonathan.knott@mh.org.au
Contact person for scientific queries
Name 93980 0
A/Prof Jonathan Knott
Address 93980 0
Royal Melbourne Hospital
300 Grattan St Parkville, VIC, 3050
Country 93980 0
Australia
Phone 93980 0
+61 3 93427009
Fax 93980 0
Email 93980 0
jonathan.knott@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Start date: immediately after publication
End date: up until 5 years after publication when it is expected that all data will destroyed as per a condition of ethics approval
Available to whom?
Anyone from an academic institution who requests it
Available for what types of analyses?
For any analysis as designed by the requesting academics
How or where can data be obtained?
The deidentifed data will be available in an easily utilised file type e.g. comma separated values after approval from our institution's human research and ethics committee.
The study protocol, statistical analysis plan, informed consent form, clinical study report and ethical approval will all be available from jonathan.knott@mh.org.au
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2771 0
Study protocol
Citation [1] 2771 0
Link [1] 2771 0
Email [1] 2771 0
jonathan.knott@mh.org.au
Other [1] 2771 0
Attachment [1] 2771 0
Type [2] 2772 0
Statistical analysis plan
Citation [2] 2772 0
Link [2] 2772 0
Email [2] 2772 0
jonathan.knott@mh.org.au
Other [2] 2772 0
Attachment [2] 2772 0
Type [3] 2773 0
Informed consent form
Citation [3] 2773 0
Link [3] 2773 0
Email [3] 2773 0
jonathan.knott@mh.org.au
Other [3] 2773 0
Attachment [3] 2773 0
Type [4] 2774 0
Clinical study report
Citation [4] 2774 0
Link [4] 2774 0
Email [4] 2774 0
jonathan.knott@mh.org.au
Other [4] 2774 0
Attachment [4] 2774 0
Type [5] 2775 0
Ethical approval
Citation [5] 2775 0
Link [5] 2775 0
Email [5] 2775 0
jonathan.knott@mh.org.au
Other [5] 2775 0
Attachment [5] 2775 0
Summary results
No Results