None listed
Conditions
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.
Interventions
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
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"
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
• Refusal to participate • Those who cannot communicate e.g. dementia, language barriers, or are too ill
Outcome results
None listed