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

Phase 3

Completed

• Conditions: gingivostomatitis; hand, foot and mouth disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; ulcerative pharyngitis; herpangina

• Registration Number: ACTRN12609000566235
• Lead Sponsor: Sandy (Alexander) M Hopper

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[60 minutes after administration of the treatment]