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Clinical Trials/ACTRN12609000566235
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

Sponsor
Sandy (Alexander) M Hopper

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