COOLAID final dataset
The University of MelbourneDataset 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.Identifiers
Source Study
Trial name (public)
Comparison of lidocaine preparations and their analgesic efficacy in epigastric painTrial 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 .... Read more
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 .... Read more
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 scaleTimepoint: 60 minutes after the medication, a one-off dose, has been administered
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