Plain English Summary
Background and study aims
Treating of background pain in burned patients is difficult and requires high doses of opioids (pain relief medications) which often results in unfavorable symptoms and sometimes a life threatening complications such as respiratory depression. Intravenous administration (inserting liquids directly into a vein) of lidocaine (a type of opioid) showed a good effect in treating pain in burns. It has a peripheral and central effect on pain receptors with a significant decrease in release of prostaglandin E for burns in vivo, which is considered one of the most important mediators for peripheral pain. The aim of this study is to compare the opioids sparing effect among patients who received lidocaine IV infusion with that of those who received a placebo (normal saline).
Who can participate?
Adults aged 18 to 70 with burns that are more than 10 percent of their total body surface area .
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the interventional drug of lidocaine intravenously through a vein, this is continued for seven days. Those in the second group receive normal saline for seven days.
What are the possible benefits and risks of participating?
The patients who were given lidocaine can benefit from the decreased pain killer doses. Adverse effects were meticulously monitored and dealt with immediately. Participants are followed up to measure their opioid consumption and pain levels at baseline, days 1-3 and days 4-6.
Where is the study run from?
Linkoping Burn Center (Sweden)
When is the study starting and how long is it expected to run for?
Jan 2003 to April 2017
Who is funding the study?
Linkoping University (Sweden)
Who is the main contact?
Professor Folke Sjoberg
Effect of intravenous infusion of Xylocard on morphine consumption among patients with burns > 10% TBSA
Intravenous infusion of lidocain will results in decreased opioid consumption in burned patients.
The Linköping Ethical Review Board, 2003/03/11, ref. (03-073)
Single-centre double-blinded three block randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Pain in burned patients
Participants are randomly allocated to one of two groups: the intervention group or the control group.
Interventional drug: intravenous infusion of lidocaine starting with bolus dose 1 mg/kg, followed by lidocaine infusion 6o ml/hour for four hours 4mg/ml, then continuous infusion 45 ml/hour 4mg/ml for seven days.
Control Group: Equivalent volume of 0.9% Sodium Chloride starting with bolus dose, followed by lidocaine infusion 6o ml/hour for four hours, then continuous infusion 45 ml/hour for seven days.
Participants are followed up to measure their opioid consumption and pain levels at baseline, days 1-3 and days 4-6.
Xylocard : lidocaine, AstraZeneca
Primary outcome measures
Opioid consumption (intravenous and oral in milligram/day) is measured using the recordings from both infusion pump and nurses’ written doses administered at baseline day 0, days 1-3 and days 4-6.
Secondary outcome measures
Pain is measured using the visual analogue scale (measured six times per day) at baseline day 0, days 1-3 and days 4-6.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Burns more than 10 Total body surface area (tbsa)
2. Aged between 18 and 70 years
3. Adminstration of patient controlled anaglesia (morphine)
Target number of participants
Participant exclusion criteria
1. Untreated AV-block type II or III
2. Known heart failure
3. Known allergy to local anaesthesia
4. Liver cirrhosis and severe renal dysfunction
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Linkoping Burn Center
Linkoping University Hospital
Linköping University, LiU
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The participant level data consists of anonymous numbers in a data sheet, which is stored within the data security system of the hospital where the researchers are working. There is no web link available as the security system does not allow external visitors. The process for requesting access can be initiated by the use of the contact details below.
Consent from participants was obtained for publication of the analysed results of the study. No consent was obtained for distributing individual data to external interests.
Intention to publish date
Participant level data
Stored in repository
Results - basic reporting