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

gingivostomatitis hand, foot and mouth disease ulcerative pharyngitis herpangina

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

Inclusion Criteria1

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).

Exclusion Criteria12

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