Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/11/2017
Date assigned
08/01/2018
Last edited
08/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
folke.sjoberg@liu.se

Trial website

Contact information

Type

Public

Primary contact

Prof Folke Sjoberg

ORCID ID

http://orcid.org/0000-0002-5903-2918

Contact details

Burn Centre
University Hospital in Linkoping
Linkoping
58185
Sweden
+46 (0)101 031820
folke.sjoberg@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Xylocard 001

Study information

Scientific title

Effect of intravenous infusion of Xylocard on morphine consumption among patients with burns > 10% TBSA

Acronym

Study hypothesis

Intravenous infusion of lidocain will results in decreased opioid consumption in burned patients.

Ethics approval

The Linköping Ethical Review Board, 2003/03/11, ref. (03-073)

Study design

Single-centre double-blinded three block randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain in burned patients

Intervention

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.

Intervention type

Drug

Phase

Phase IV

Drug names

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

18/01/2003

Overall trial end date

04/10/2017

Reason abandoned

Eligibility

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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

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

11/07/2005

Recruitment end date

10/09/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

Linkoping Burn Center
Linkoping University Hospital
Linkoping
58185
Sweden

Sponsor information

Organisation

Linkoping University

Sponsor details

Garnsionsgatan
Linkoping
58185
Sweden
+46 (0)101 030 000
liu@liu.se

Sponsor type

University/education

Website

www.liu.se

Funders

Funder type

University/education

Funder name

Linköpings Universitet

Alternative name(s)

Linköping University, LiU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

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

10/01/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes