A randomized, double‐blind, multicentre controlled trial of ibuprofen versus acetaminophen and placebo for symptoms of acute otitis media in children

Abstract

Two hundred and nineteen children (boys: 56%, girls: 44%) were included in a randomized, double-blind, multicentre (4 centres) controlled trial designed to assess the efficacy and safety of ibuprofen (IBU) in the treatment of 1 to 6 year-old children with otoscopically proven acute otitis media (AOM), either unilateral or bilateral. They randomly received 10 mg/kg IBU (n = 71), or acetaminophen (PARA) (n = 73) or placebo (PLA) (n = 75), orally, tid, for 48 hours. All received oral cefaclor (Alfatil, Lilly, France) for seven days. They were evaluated before (D0) and at the end of treatment (D2). The main criterion of response was the aspect (landmarks and color) of the tympanic membrane assessed on a semi-quantitative scale from 0 to 6. Other criteria, assessed on semi-quantitative scales, included relief of pain (0 or 1), rectal temperature (0 to 2), and overall evaluation by parents of the improvement of quality of life on three items: appetite (0 to 2), sleep (0 to 2), and playing activity (0 to 2). The results at D2 were as follows: there was no significant difference between treatment groups as to the main criterion, but only a trend for IBU and PARA to do better than PLA but not for IBU to do better than PARA. From these data there is no argument to emphasize the utility of non-steroidal anti-inflammatory drugs (NSAIDs) in treating the inflammatory signs of the tympanic membrane in otitis. There was a statistically significant difference between treatment groups at D2 for pain, IBU being superior to PLA (P < 0.01): 7%, 10% and 25% of the children were still suffering at D2 in the IBU, PARA and PLA treatment groups, respectively. The difference between PARA and PLA for pain was not statistically significant. There was no significant difference between treatment groups for the other criteria. All treatments were well and equally tolerated. Although no significant difference was found between the treatment groups on the aspect of the tympanic membrane, the efficacy of IBU was evidenced on the relief of pain, the symptom that most disturbs the child.

Health-related quality of life in children with otitis media

“…The manual search and expert discussion yielded one extra article [28]. After applying the criteria for inclusion and exclusion, only 13 articles remained for inclusion [29,30,[35][36][37][38][39][40][41][42][43][44]. In addition, we included results regarding reliability and validity of the TAIQOL from our own work published in a thesis [45].…”

“…The setting of the studies varied, eight studies were part of a multi-centre trial [28,35,37,38,41,[43][44][45]. Most study-populations consisted of children with chronic or recurrent otitis media ( Table 2).…”

“…Those who had recovered from AOM continued to score two to four times worse on these measurements compared to healthy controls during 6-12 weeks of follow-up. Bertin et al [37] reported sleep and appetite to be moderate to severely affected at the start of an acute episode of OM.…”

The Diagnosis and Management of Acute Otitis Media

“…57 Antibiotic therapy of AOM does not provide symptomatic relief in the first 24 hours 58-61 and even after 3 to 7 days, there may be persistent pain, fever, or both in 30% of children younger than 2 years. 62 In contrast, analgesics do relieve pain associated with AOM within 24 hours 63 and should be used whether antibiotic therapy is or is not prescribed; they should be continued as long as needed. The AAP published the policy statement "The Assessment and Management of Acute Pain in Infants, Children, and Adolescents" 64 to assist the clinician in addressing pain in the context of illness.…”

Impact of Ibuprofen Therapy in the Outcome of Experimental Pneumococcal Acute Otitis Media Treated With Amoxicillin or Erythromycin

“…Most experts recommend empirical antimicrobial treatment of AOM in children to eradicate the pathogen and the use of an anti-inflammatory or analgesic drug such as ibuprofen or acetaminophen to relieve the symptoms (2,3). Acetaminophen acts as a weak inhibitor of the synthesis of prostaglandins inhibiting cyclooxygenase (COX)-2-dependent pathways (4).…”