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?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000566235

Enrollment

101

Registered

2009-07-10

Start date

2009-11-09

Completion date

2012-11-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Months to 8 Years

Healthy volunteers

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).

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

Outcome results