Data

COOLAID final dataset

The University of Melbourne

Dataset description

Demographics and outcome data for 88 patients randomized to antacid plus either lidocaine in one of two formulation, or additional antacid for management of epigastric pain in the Emergency Department.
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Subjects

Emergency medicine | Pain |

Source Study

Trial acronym

Not available

Trial ID

ACTRN12619000928112

Purpose

Treatment

Phase

Not Applicable

Funding

Hospital,Royal Melbourne Hospital

Scientific enquiries

A/Prof Jonathan Knott

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 treati ....
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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.

Key Exclusion Criteria

• Refusal to participate • Those who cannot communicate e.g. dementia, language barriers, or are too ill

Can healthy volunteers participate?

No

 

Population

Sample Size    89

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    dyspepsia , gastric pain , indigestion

Condition code    Anaesthesiology , Emergency medicine , Oral and Gastrointestinal

Intervention

Intervention code Treatment: Drugs

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 pre ....
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Comparison

Control group Active

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

Outcomes

Outcome: analgesic efficacy in acute epigastric pain measured by change in visual analogue pain scale
Timepoint: 60 minutes after the medication, a one-off dose, has been administered

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

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 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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au