A double blind, randomised placebo controlled trial of topical 2% viscous
lidocaine in improving oral intake in children with painful infectious mouth
conditions.
Author(s): Hopper SM, Babl FE, McCarthy M, Tancharoen C, Lee KJ, Oakley E.
Affiliation(s): Department of Emergency Medicine, Royal Children's Hospital, and Department of
Paediatrics, Faculty of Medicine, Dentistry and Health Services, University of
Melbourne, Flemington Rd, Parkville, Victoria 3052, Australia.
sandy.hopper@rch.org.au
Publication date & source: 2011, BMC Pediatr. , 11:106
BACKGROUND: Painful infectious mouth conditions are a common presentation to
emergency departments. Although self limiting, painful ulcerative lesions and
inflamed mucosa can decrease oral intake and can lead to dehydration. Oral
analgesia is of limited efficacy and is often refused by the patient. Despite
widespread use of oral 2% viscous lidocaine for many years, there is little
evidence for its efficacy as an analgesic and in aiding oral intake in children
with painful infectious mouth conditions. This study aims to establish the
effectiveness of 2% viscous lidocaine in increasing oral intake in these children
by comparing it with placebo.
METHODS/DESIGN: This study is a randomised double-blind placebo controlled trial
of children between 6 months and 8 years of age with painful infectious mouth
conditions defined as 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. It
will be conducted at a single tertiary paediatric emergency department in
Melbourne Australia.20 patients have already been randomised to receive 2%
lidocaine or placebo in a pilot study to determine the sample size in a
preplanned adaptive design. A further 80 patients will be randomised to receive
either 2% lidocaine or placebo. The placebo agent is identical to lidocaine in
terms of appearance, flavour and smell. All clinical and research staff involved,
patients and their parents will be blinded to treatment allocation.The primary
endpoint is the amount of fluid ingested by each child, expressed in ml/kg,
within 60 minutes from the time of administration of the study mixture. Secondary
endpoints are the proportion of patients ingesting 5 ml/kg and 10 ml/kg at 30 and
60 minutes after drug administration and the incidence of adverse events. Longer
term outcomes will include the proportion of patients requiring hospital
admission and length of emergency department stay.
DISCUSSION: This trial will define the role of 2% lidocaine in the treatment of
painful infectious mouth conditions.
TRIAL REGISTRATION: The trial is registered with the Australian and New Zealand
Clinical Trials Registry--ACTRN12609000566235.
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