ILLUSTRATIVE CASE
A mother brings her 3-year-old son to your office first thing in the morning. The boy has fever and right ear pain. You see that the tympanic membrane is dull, red, and bulging. The mother has been up most of the night with her child. She implores you to “do something.” She is exhausted and her son is crying and holding his right ear. You know that antibiotics will not provide immediate pain relief and oral analgesics will take a while to help. What can you offer that will help right away?
Until this study, we’ve had only 1 placebo-controlled trial to guide how we manage a big problem. Big in terms of distress to parents and children, and in sheer numbers—acute otitis media (AOM) is extremely common in children.2,3
Routine antibiotics: Woeful lack of evidence
Even when antibiotics are indicated, pain relief is minimal and takes several days.4-8 Despite “a woeful lack of substantial evidence on the question of antibiotic therapy” for AOM, it is the most common reason for the prescription of antibiotics in children.4,6 A Cochrane review showed that antibiotics have no effect on recurrence of AOM or complications, including hearing impairment.5 The same review showed no pain reduction in 24 hours and only 30% pain reduction in 2 to 7 days with antibiotic use.5 Antibiotics clearly have a minimal role in providing pain relief for AOM.
Oral analgesics too slow
Oral analgesic use in AOM has been studied and has shown good results. We calculated the number needed to treat (1.0 divided by the absolute risk reduction) for both ibuprofen (number needed to treat [NNT]=5) and acetaminophen (NNT=6) from data in the 1996 trial by Bertin et al.9
It is a common practice in the United States to treat AOM with oral analgesics. However, the onset of pain relief with oral medications can be slow and the relief is generally not complete, so oral medications are not immediately helpful to meet the needs of our crying 3-year-old patient and his exhausted mother.
Topical anesthetics
To our knowledge, prior evidence on the efficacy of topical anesthetics is limited to 1 placebo-controlled trial. A randomized trial by Hoberman et al,10 with 54 subjects, showed a statistically significant 25% reduction in pain with the analgesic drops Auralgan (containing antipyrine, benzocaine, and glycerine) at 30 minutes when compared with olive oil. A 2006 Cochrane review11 did not include the Bolt et al trial1 described in this PURL, but did include the Hoberman trial10 and 3 trials that compared a topical anesthetic with naturopathic herbal ear drops for AOM pain, and the review concluded that evidence was insufficient.
Topical anesthetic plus oraI analgesia for earache relief
Bolt P et al.1
STUDY SUMMARY: Pain measured by visual analogue, Bieri faces scales
This double-blind, randomized, placebo-controlled trial1 compared aqueous lidocaine 2% drops with saline drops in the ear, for reducing pain due to AOM in patients 3 to 17 years of age. The trial was conducted at an Australian children’s hospital emergency room. The study evaluated “lignocaine,” the name for lidocaine in Australia.
Emergency physicians instilled 3 drops of either lidocaine or saline into the affected ear in the 2 groups (n=31 in the study group and n=32 in the placebo group). Patients, parents, treating physicians, and staff administering ear drops and assessing pain were blinded to group assignment. Doctors measured pain at baseline and after 30 minutes and patients measured pain at baseline, 10, 20, and 30 minutes after the drops were instilled, using the Bieri faces pain scale and a visual analogue scale.12
Lidocaine reduced pain scores by 50% from baseline at 10 and 30 minutes compared with saline. No serious side effects were noted at 30 minutes, although 3 patients in the lidocaine group complained of mild dizziness the next day. The treating physician prescribed paracetamol (equivalent to acetaminophen) for participants in both the lidocaine and the placebo group at their discretion. The proportion given paracetamol was similar in both groups.
