Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000156482
Ethics application status
Approved
Date submitted
15/02/2007
Date registered
6/03/2007
Date last updated
6/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Nebulised Lignocaine Reduce Children's Pain When a Nasogastric Tube is Inserted?
Scientific title
Randomised Controlled Trial of Nebulised Lignocaine Versus Placebo for Relief of Pain of Nasogastric Tube Insertion in Children.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain and distress associated with nasogastric tube insertion in children. 1658 0
Condition category
Condition code
Other 1763 1763 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial solution (comprising aqueous 2% Lignocaine at 4mg/kg dose in total 5mls trial solution in the experimental group versus 5mls normal saline in the control group) will be administered using a face mask and a compressed gas-powered jet nebuliser (Hudson Respiratory Care Inc., Temecula, CA, USA) with an oxygen flow rate of 6L/min. over a period of 10 minutes. This will occur 10 minutes before nasogastric intubation. Nasogastric tube insertion will proceed in a standard protocolised manner for all patients. The study will last for one year or until 52 patients have been successfully recruited.
Intervention code [1] 1604 0
Treatment: Drugs
Comparator / control treatment
5mls normal saline in the control group will be administered using a face mask and a compressed gas-powered jet nebuliser (Hudson Respiratory Care Inc., Temecula, CA, USA) with an oxygen flow rate of 6L/min.
Control group
Placebo

Outcomes
Primary outcome [1] 2464 0
Pain and distress of nasogastric tube insertion as measured by Faces, Legs, Activity, Cry, Consolability (FLACC) pain and distress score - will be scored by independent analysts using video analysis of children undergoing procedure.
Timepoint [1] 2464 0
This will be measured at the following timepoints: 5 minutes before nebuliser application; during nebuliser application; period after nebulisation (5 minutes before nasogastric tube insertion); during nasogastric tube insertion; 5 minutes after nasogastric tube insertion.
Secondary outcome [1] 4227 0
Visual Analogue Scale (VAS) measurement of pain and distress of children undergoing nasogastric tube insertion - measured by independent analysts using video analysis.
Timepoint [1] 4227 0
This will be measured at the following timepoints: 5 minutes before nebuliser application; during nebuliser application; period after nebulisation (5 minutes before nasogastric tube insertion); during nasogastric tube insertion; 5 minutes after nasogastric tube insertion.

Eligibility
Key inclusion criteria
1. Children presenting to our Emergency Department with a clinical indication for nasogastric tube insertion.
Minimum age
1 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Need for immediate nasogastric tube insertion (e.g. acute gastric dilatation). 2. Non-English speaking parent/guardian - only when appropriate interpreter services cannot be accessed expeditiously (i.e. where nasogastric tube insertion is delayed by more than one hour). 3. Allergy to Lignocaine or local anaesthetic. 4. Significant co-morbid disease (asthma/chronic renal or hepatic impairment/epilepsy/cardiac disease/cognitive impairment or neurological disease).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified during clinical consultation in the emergency department. They and their parents will be given written and verbal information about the study. After suitability for inclusion in the study is checked, consent will be obtained if the family are willing.The patient will be randomised to either lignocaine or placebo by the attending clinician by the allocation of a pre-randomised numbered vial corresponding to the study mumber of that particular patient. Patient numbers will be allocated on a consecutive basis of recruitment to the study. Thus, allocation was concealed using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The attending clinician, nurse proceduralist, and patient will all be blinded to the identity of the trial solution. The attending clinician and nurse proceduralist may be, but not always, the therapist and/or assessor for the study. This is because our research team is made up of practising clinicians within our department.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1915 0
Charities/Societies/Foundations
Name [1] 1915 0
Murdoch Children's Research Institute (MCRI) Project Grant
Country [1] 1915 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital (Emergency Department)
Address
Country
Australia
Secondary sponsor category [1] 1727 0
Other
Name [1] 1727 0
Murdoch Children's Research Institute (MCRI)
Address [1] 1727 0
Country [1] 1727 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3562 0
Royal Children's Hospital Emergency Department
Ethics committee address [1] 3562 0
Ethics committee country [1] 3562 0
Australia
Date submitted for ethics approval [1] 3562 0
Approval date [1] 3562 0
14/11/2006
Ethics approval number [1] 3562 0
26096

Summary
Brief summary
Nasogastric tubes are often used in children to give them fluids or medications or to drain their stomach. This involves the insertion of a narrow tube into their nostril and then down into their stomach. We know that this is a very safe and effective way of managing a number of problems in children. However, we also know that this is a painful procedure and we are looking for a way to relieve this pain.
Lignocaine is commonly used in children to provide local anaesthetic before painful procedures. It is given in many ways, as an injection, applied to the mouth as a gel and sprayed in the mouth and nose, but it has not been licensed for administration by a nebuliser. Administering a medication in this way means that it is given through a mask so that it can be breathed in. The use of lignocaine in the manner proposed in this study is experimental. However, lignocaine has been administered by a nebuliser to children having different procedures and shown to be safe. It has also been given to adults by nebuliser before the insertion of a nasogastric tube and was shown to make this less painful.
We will be asking families for consent for their child to participate in this study to find out whether administering nebulised lignocaine before inserting a nasogastric tube reduces the pain that the child feels. We aim to include 52 children in this study. Half of the children (26) will get the study drug (nebulised lignocaine) while the other half will get a placebo (nebulised salt water).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27538 0
Address 27538 0
Country 27538 0
Phone 27538 0
Fax 27538 0
Email 27538 0
Contact person for public queries
Name 10793 0
Ronan O'Sullivan
Address 10793 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 10793 0
Australia
Phone 10793 0
+61 3 93456592
Fax 10793 0
Email 10793 0
[email protected]
Contact person for scientific queries
Name 1721 0
Ronan O'Sullivan
Address 1721 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 1721 0
Australia
Phone 1721 0
+61 3 93456592
Fax 1721 0
Email 1721 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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