ANZCTR - Registration

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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

28/10/2021

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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

dyspepsia

indigestion

gastric pain

Condition category

Condition code

Emergency medicine

Other emergency care

Anaesthesiology

Pain management

Oral and Gastrointestinal

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]

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]

analgesic efficacy in acute epigastric pain measured by change in visual analogue pain scale

Timepoint [1]

60 minutes after the medication, a one-off dose, has been administered

Secondary outcome [1]

analgesic efficacy in acute epigastric pain measured by change in visual analogue pain scale

Timepoint [1]

30 minutes after the medication, a one-off dose, has been administered

Secondary outcome [2]

Taste of the three solutions, using a visual analogue scale

Timepoint [2]

60 minutes after the medication, a one-off dose, has been administered

Secondary outcome [3]

Texture of the three solutions, using a visual analogue scale

Timepoint [3]

60 minutes after the medication, a one-off dose, has been administered

Secondary outcome [4]

Bitterness of the three solutions, using a visual analogue scale

Timepoint [4]

60 minutes after the medication, a one-off dose, has been administered

Secondary outcome [5]

Patient acceptability of the three solutions, using a visual analogue scale

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

5/07/2019

Actual

5/07/2019

Date of last participant enrolment

Anticipated

1/09/2019

Actual

1/09/2019

Date of last data collection

Anticipated

1/09/2019

Actual

1/09/2019

Sample size

Target

123

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 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Melbourne Hospital

Address [1]

300 Grattan st Parkville, Victoria 3050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Melbourne Hospital

Address

300 Grattan St Parkville Victoria 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Research Ethics Committee

Ethics committee address [1]

300 Grattan St
Parkville, Victoria 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/01/2019

Approval date [1]

22/05/2019

Ethics approval number [1]

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

A/Prof Jonathan Knott

Address

Royal Melbourne Hospital
300 Grattan St Parkville, VIC, 3050

Country

Australia

Phone

+61 3 93427009

Fax

jonathan.knott@mh.org.au

Contact person for public queries

Name

Jonathan Knott

Address

Royal Melbourne Hospital
300 Grattan St Parkville, Vic, 3050

Country

Australia

Phone

+61 3 93427000

Fax

jonathan.knott@mh.org.au

Contact person for scientific queries

Name

Jonathan Knott

Address

Royal Melbourne Hospital
300 Grattan St Parkville, VIC, 3050

Country

Australia

Phone

+61 3 93427009

Fax

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?

Doc. No.	Type	Email
2771	Study protocol	jonathan.knott@mh.org.au
2772	Statistical analysis plan	jonathan.knott@mh.org.au
2773	Informed consent form	jonathan.knott@mh.org.au
2774	Clinical study report	jonathan.knott@mh.org.au
2775	Ethical approval	jonathan.knott@mh.org.au

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	Antacid Monotherapy Is More Effective in Relieving Epigastric Pain Than in Combination With Lidocaine: A Randomized Double-blind Clinical Trial.	2020	https://dx.doi.org/10.1111/acem.14069

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

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