CompletedPhase 3ACTRN12609000566235

A double blind, randomised placebo controlled trial of topical 2% viscous lignocaine in improving oral intake in children with painful infectious mouth conditions.

For children with painful infectious mouth conditions and poor oral intake, does topical 2% viscous lignocaine improve oral intake?


Sponsor

Sandy (Alexander) M Hopper

Enrollment

100 participants

Start Date

Nov 9, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 8 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a numbing gel (lignocaine) applied inside the mouth helps children aged 6 months to 8 years drink more fluids when they have painful mouth infections like hand, foot and mouth disease or cold sores.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

administration of 0.15 ml/kg of 2% viscous lignocaine, topically to the oral cavity once only

administration of 0.15 ml/kg of 2% viscous lignocaine, topically to the oral cavity once only


Locations(1)

Australia

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ACTRN12609000566235