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Trial registered on ANZCTR


Registration number
ACTRN12609000566235
Ethics application status
Approved
Date submitted
9/07/2009
Date registered
10/07/2009
Date last updated
3/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind, randomised placebo controlled trial of topical 2% viscous lignocaine in improving oral intake in children with painful infectious mouth conditions.
Scientific title
For children with painful infectious mouth conditions and poor oral intake, does topical 2% viscous lignocaine improve oral intake?
Secondary ID [1] 260062 0
the Painful Oral Ulcer Treatment trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gingivostomatitis 237199 0
ulcerative pharyngitis 237200 0
hand, foot and mouth disease 237201 0
herpangina 237202 0
Condition category
Condition code
Oral and Gastrointestinal 237521 237521 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
administration of 0.15 ml/kg of 2% viscous lignocaine, topically to the oral cavity
once only
Intervention code [1] 236902 0
Treatment: Drugs
Comparator / control treatment
the placebo is water mixed with methylcellulose, gelatin and cherry flavoring
0.15 ml/kg of this mixture is administered topically to the oral cavity
once only
Control group
Placebo

Outcomes
Primary outcome [1] 238331 0
The primary outcome is the amount of fluid ingested by each child, expressed in ml/kg, as recorded by the treating nurses on a standard fluid balance chart
Timepoint [1] 238331 0
60 minutes after administration of the treatment
Secondary outcome [1] 244735 0
the proportion of subjects in each arm to have ingested more than 10 ml/kg of fluid
Timepoint [1] 244735 0
30 minutes after administration of the study solution
Secondary outcome [2] 244736 0
Incidence of adverse effects (seizures, cardiac arrhythmia, aspiration as defined by presence of cough and increased respiratory rate or decreased saturation or onset of new adventitial breath sounds)
Timepoint [2] 244736 0
90 minutes after administration of the treatment
Secondary outcome [3] 244737 0
the proportion of patients who undergo involuntary fluid administration via intravenous or nasogastic routes
Timepoint [3] 244737 0
90 minutes after administration of the treatment
Secondary outcome [4] 262176 0
the proportion of subjects in each arm to have ingested more than 10ml/kg of fluid
Timepoint [4] 262176 0
60 minutes from the time of administration of the study mixture
Secondary outcome [5] 262178 0
The proportion of subjects in each arm to have ingested more than 20 ml/kg of fluid
Timepoint [5] 262178 0
30 minutes from the time of administration of the study mixture
Secondary outcome [6] 262179 0
The proportion of subjects in each arm to have ingested more than 20 ml/kg of fluid
Timepoint [6] 262179 0
60 minutes after administration of the study solution
Secondary outcome [7] 262180 0
the proportion of subjects who experience vomiting
Timepoint [7] 262180 0
90 minutes after administration of the study solution
Secondary outcome [8] 262181 0
The proportion of subjects who are admitted to hospital (both to the hospital and to the Emergency department short stay unit)
Timepoint [8] 262181 0
discharge or admission to hospital
Secondary outcome [9] 262182 0
Length of stay in the Emergency department (ED)
Timepoint [9] 262182 0
discharge or transfer to the ward
Secondary outcome [10] 276122 0
The proportion of subjects in each arm to have ingested more than 5 ml/kg of fluid
Timepoint [10] 276122 0
30 minutes from the time of administration of the study mixture
Secondary outcome [11] 276123 0
The proportion of subjects in each arm to have ingested more than 5 ml/kg of fluid
Timepoint [11] 276123 0
60 minutes from the time of administration of the study mixture

Eligibility
Key inclusion criteria
gingivostomatitis (herpetic or non herpetic), ulcerative pharyngitis, herpangina and hand foot and mouth disease as assessed by the treating clinician, in association with a history of poor oral fluid intake (as assessed by parent and defined as oral fluid intake of less than 10ml/kg of fluid in the preceding 2 hours).
Minimum age
6 Months
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of more than 2 vomits in the preceding 24 hours
Presence of active painful dental disease (caries, dental abscess) or painful recent mouth trauma, mouth burn, or post-operative state (minimum of 5 days)
Systemic toxicity related to infection
Severe dehydration requiring immediate therapy

Pre-existing significant upper airway obstruction and swallowing difficulties
Known allergy to local anaesthetic, gelatine, methylcellulose, cherry flavouring, paracetamol or ibuprofen
Chronic renal or liver impairment History of epilepsy or cardiac disease Presence of acute porphyria
Presence of malignancy
Current use of anti-arrhythmic drugs, xylocaine, phenytoin, cimetidine or beta-blockers, warfarin, lithium, angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, frusemide, aspirin, salicylates, probenecid, anti-diabetic medications, zidovudine, cardiac glycosides or methotrexate.
Analgesia taken 1 hour preceding enrolment to study.
More than 1 dose of Xylocaine viscous and/or other medications containing lignocaine as an active ingredient given in this episode of illness
Non- English speaking parents/guardians

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)
Patients that fulfil the eligibility criteria will be randomised to either 2% viscous lignocaine or the placebo mixture in labelled Bottle A and a study number will be allocated. All study drugs will be packaged in blinded containers stored in the locked ED cupboard labelled only with the study details and the study number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer generated using block randomisation by the Clinical Biostatistics and Epidemiology Unit (CEBU). The randomisation will not be stratified. Sequentially numbered bottles of either study drug or placebo will be arranged according to this schedule by a pharmacist at the RCH. Once a patient has been randomised they will be given the next available study number which will equate to the next bottle (labelled Bottle A) in sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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] 237300 0
Other Collaborative groups
Name [1] 237300 0
Murdoch Children's Research Institute
Address [1] 237300 0
Royal Children's Hospital
Flemington Rd
Parkville, 3052
VIC
Country [1] 237300 0
Australia
Primary sponsor type
Individual
Name
Sandy (Alexander) M Hopper
Address
Emergency Department
Royal Children's Hospital
Flemington Rd
Parkville, 3052
VIC
Country
Australia
Secondary sponsor category [1] 236784 0
Individual
Name [1] 236784 0
Franz E Babl
Address [1] 236784 0
Emergency Department
Royal Children's Hospital
Flemington Rd
Parkville, 3052
VIC
Country [1] 236784 0
Australia
Other collaborator category [1] 755 0
Individual
Name [1] 755 0
Michelle McCarthy
Address [1] 755 0
Emergency Department
Royal Children's Hospital
Flemington Rd
Parkville, 3052
VIC
Country [1] 755 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239397 0
Royal Children's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 239397 0
Royal Children's Hospital
Flemington Rd
Parkville, 3052
VIC
Ethics committee country [1] 239397 0
Australia
Date submitted for ethics approval [1] 239397 0
29/11/2010
Approval date [1] 239397 0
13/12/2010
Ethics approval number [1] 239397 0
29070 C

Summary
Brief summary
This study looks at children with viral infections which create painful ulcers in the mouth. These ulcers can cause children to become dehydrated because the ulcers make drinking painful. This study aims to find out whether 2%viscous lignocaine, a numbing drug, helps children drink. 50 children will be given the drug and 50 children will be given a mixture which looks and tastes like the drug, but has no active medicine in it. The study will record how much fluid the children drink, and also look at whether or not any complications develop. This way, we hope to work out if 2% viscous lignocaine is a helpful medication for children with painful ulcers in the mouth.
Trial website
Trial related presentations / publications
Publications:
1. Hopper S, Babl F, McCarthy M, Tancharoen C, Lee K, Oakley E. A double blind, randomised placebo controlled trial of topical 2% viscous lidocaine in improving oral intake in children with painful infectious mouth conditions. BMC Pediatr. 2011;11:106.
2. Hopper SM, McCarthy M, Tancharoen C, Lee KJ, Davidson A, Babl FE. Topical lidocaine to improve oral intake in children with painful infectious mouth ulcers: a blinded, randomized, placebo-controlled trial. Ann Emerg Med. 2013;63(3):292-9.
3. Hopper S, McCarthy M, Tancharoen C, Lee KJ, Orsini F, Babl FE. What do clinicians perceive as a successful "trial of fluids"? A secondary assessment of a randomised controlled trial. Pediatric Emergency care. Publish Ahead of Print, POST AUTHOR CORRECTIONS, 14 July 2015.

Presentations
Topical lignocaine to improve oral intake in children with painful infectious mouth ulcers:
A blinded, randomized placebo–controlled trial. Oral Presentation, Annual Scientific Meeting, Australasian College for Emergency Medicine, Nov 2013
What do clinicians perceive as a successful "trial of fluids"? A secondary assessment of a randomised controlled trial PosterPresentation, Annual Scientific Meeting, Australasian College for Emergency Medicine, Nov 2013

Public notes

Contacts
Principal investigator
Name 29873 0
Dr Sandy M Hopper
Address 29873 0
Royal Children's Hospital
Flemington Rd
Parkville, 3052
VIC
Country 29873 0
Australia
Phone 29873 0
+61393456592
Fax 29873 0
Email 29873 0
sandy.hopper@rch.org.au
Contact person for public queries
Name 13120 0
Dr Sandy (Alexander) M Hopper
Address 13120 0
Emergency Department
Royal Children's Hospital
Flemington RD
Parkville, 3052
VIC
Country 13120 0
Australia
Phone 13120 0
+61393456592
Fax 13120 0
Email 13120 0
sandy.hopper@rch.org.au
Contact person for scientific queries
Name 4048 0
Dr Sandy (Alexander) M Hopper
Address 4048 0
Emergency Department
Royal Children's Hospital
Flemington RD
Parkville, 3052
VIC
Country 4048 0
Australia
Phone 4048 0
+61393456592
Fax 4048 0
Email 4048 0
sandy.hopper@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary