ANZCTR - Registration

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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.

Condition category

Condition code

Other

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]

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]

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]

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]

Visual Analogue Scale (VAS) measurement of pain and distress of children undergoing nasogastric tube insertion - measured by independent analysts using video analysis.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Murdoch Children's Research Institute (MCRI) Project Grant

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Children's Hospital (Emergency Department)

Address

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Murdoch Children's Research Institute (MCRI)

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital Emergency Department

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/11/2006

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ronan O'Sullivan

Address

Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052

Country

Australia

Phone

+61 3 93456592

Fax

ronan.osullivan@rch.org.au

Contact person for scientific queries

Name

Ronan O'Sullivan

Address

Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052

Country

Australia

Phone

+61 3 93456592

Fax

ronan.osullivan@rch.org.au

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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