Phase III, randomized, double-blind, placebo-controlled trial of topical 2 % lidocaine for the prevention and treatment of oral mucosal pain in children

Coudert, Amélie E.; Ostertag, Agnès; Baaroun, Vanessa; Artaud, Catherine; Ifi-Naulin, Chantal; Druo, Jean-Patick; Princ, G; Descroix, Vianney

doi:10.1007/s00784-013-1063-7

Cited by 17 publications

(15 citation statements)

References 7 publications

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“…In Germany, it can be applied to children without age restriction. In a recently published clinical study in patients between 6 years and 15 years with pain because of clamp placement, oral trauma, or aphthous ulcers, the identical medicinal product (also due to regulatory circumstances called a cream in France) showed significant superiority compared to the respective placebo formulation [ 10 ]. In the present study, significant superiority could be measured in children even down to 4 years of age.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

Wolf

Otto

2015

International Journal of Pediatrics

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Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number 2011-005336-25) was designed to generate efficacy and safety data for a lidocaine gel (2%) in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4–8 years, average age 6.4 years, treated with verum or placebo and 6 months–<4 years, average age 1.8 years, treated only with verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

Wolf

Otto

2015

International Journal of Pediatrics

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“…These topical agents are recommended for the prevention and treatment of oral mucosa pain, especially in children. The main indications are symptomatic treatment of minor injuries (such as trauma or aphtous ulcers) of oropharynx membranes or prevention of iatrogenic pain produced during painful dental procedures such as anesthetic injection or clamp placement [22].…”

Section: Lidocainementioning

confidence: 99%

New Patents on Topical Anesthetics

Cantisani¹,

Macaluso²,

Frascani³

et al. 2014

IAD

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Anesthesia is defined as a total or partial loss of sensation and it may be general, local or topical, depending on the method of drug administration and area of the body affected. General anesthesia is a reversible state of unconsciousness produced by anesthetic agents, characterized by amnesia, muscle relaxation and loss of sensitivity to pain of the whole body. General anesthetic drugs can be classified into two main groups according to their predominant molecular pharmacological effects: volatile and intravenous agents. Local anesthesia produce a reversible loss of sensation in a portion of the body and it reversibly block impulse conduction along nerve axons and other excitable membrane. All local anesthetics (LA) are membrane stabilizing drugs; they reversibly decrease the rate of depolarization and repolarization of excitable membranes. They act mainly by inhibiting sodium influx through sodium-specific ion channels in the neuronal cell membrane, in particular the voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The main local anesthetic (LA) agents for skin anesthesia are benzocaine (aminoester), prilocaine and lidocaine (aminoamides) which are commercially available as gels, ointments and creams (benzocaine and eutectic mixture of lidocaine and prilocaine) or as a bioadhesive (lidocaine) with different compositions (vehicles and excipients) for adults or pediatric use. Topical anesthetics decrease anxiety, pain and discomfort during cutaneous procedures and provide effective analgesia with rapid onset, prolonged duration and minimal side effects. This article outlines the different classes of topical anesthetics available and gives an overview of the mechanism of action, metabolism of each different class, of the possible complications that can occur because of their use and their possible treatment options and new patents.

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“…We also believe that lidocaine application should ideally involve rubbing of the ulcerated mucosa in order to guarantee an appropriate penetration of the active principle,4 which was not done in this study. In addition, it is not obvious that the duration of mouthwash or gargle is long enough to see an effect of lidocaine, especially in the case of large and extremely painful ulcerations.…”

Section: Commentarymentioning

confidence: 99%

A viscous lidocaine mouthwash is no better than placebo for improving oral intake in children with painful mouth ulcers

Descroix

Coudert

2014

Evid Based Med

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Phase III, randomized, double-blind, placebo-controlled trial of topical 2 % lidocaine for the prevention and treatment of oral mucosal pain in children

Cited by 17 publications

References 7 publications

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

New Patents on Topical Anesthetics

A viscous lidocaine mouthwash is no better than placebo for improving oral intake in children with painful mouth ulcers

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