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Three Part Question

In [children presenting with painful oral lesions], is [topical lidocaine compared to placebo], more effective in [reducing pain and improving oral intake]?

Clinical Scenario

A 6-year-old girl presents to the Emergency Department with two days of fever, mouth pain, and poor oral intake consistent with hand-foot-mouth disease. The parents ask you what they can do to maintain adequate oral intake while the patient is ill.

Search Strategy

Medline 1966-07/19 using PubMed, Cochrane Library (2019), and Embase.
[(exp lidocaine OR exp lignocaine OR exp xylocaine) AND (mouth ulcers OR gingivostomatitis OR aphthous ulcer OR herpetic ulcer OR stomatitis)]. Limit to English language and children.

Search Outcome

19 studies were identified; two addressed the clinical question.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Hopper SM et al. Mar 2014 Australia	Children 6 months to 8 years of age with gingivostomatitis, ulcerative pharyngitis, herpangina, or hand, foot, and mouth disease, with a history of poor feeding.	RCT	Oral intake in mL/kg in those who received viscous lidocaine vs placebo	Similar in both groups	Convenience sample, limited age range studied, no pain scores collected, no long-term data, possible that patients could detect numbness from lidocaine
			Proportion of children ingesting 5, 10, 20 mL/kg of fluid within 0 to 30 minutes and 0 to 60 in each group.	Similar in both groups
Wolf D, Otto J. Nov 2015 Germany	6 months to 8 years with any area of pain in the mouth at a clinical trial facility. Group I (4 yrs to 8 yrs) was randomly allocated to either intervention or placebo. Group II (6 mos to <4 yrs) was just given intervention without comparison	RCT	Reduction in pain 10 minutes after application	Statistically significant reduction in pain in both groups	Did not measure fluid intake, children under 4 years were not given placebo, not emergency department patients, pain initially rated by one person (patient vs parent) sometimes rated by someone else after application, poor description of results, financed by pharmaceutical company.
			Child satisfaction as rated by parent	No statistically significant change between groups

Comment(s)

The two randomized clinical trials described above suggest that while there may be improved pain scores in patients with oral ulcers who have been treated with topical lidocaine, it does seem to improve oral intake. If the primary clinical concern in these patients is poor oral intake, there is no evidence that topical lidocaine is of any benefit. If topical viscous lidocaine is prescribed for pain control, providers should be aware of the adverse effects of lidocaine, and a potentially higher risk of overdose in pediatric patients. It should be noted that the mainstay of treatment for painful oral ulcers includes over-the-counter analgesia, such as ibuprofen or acetaminophen, as well as ice chips, popsicles, and small sips of fluid.

Clinical Bottom Line

In healthy pediatric patients with painful oral ulcers, treatment with viscous lidocaine does not seem to improve oral intake, although it may provide some pain relief.

References

1. Hopper SM, McCarthy M, Tancharoen C, Lee KJ, Davidson A, Babl FE. Topical lidocaine to improve oral intake in children with painful infectious mouth ulcers: a blinded, randomized, placebo-controlled trial. Ann Emerg Med 2014 Mar;63(3):292-9
2. Wolf D, Otto J. 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 Int J Pediatr 2015;2015:141767. doi: 10.1155/2015/141767. Epub 2015 Nov 29.