ACTRN12609000566235CompletedPhase 3
For children with painful infectious mouth conditions and poor oral intake, does topical 2% viscous lignocaine improve oral intake?
Sandy (Alexander) M Hopper0 sites100 target enrollmentStarted: July 10, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 6 Months to 8 Years (—)
- Sex
- All
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
Investigators
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