Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children

Abstract

Paracetamol (acetaminophen) or non-steroidal antiinflammatory drugs, alone or combined, for pain relief in acute otitis media in children (Review)Sjoukes. A B S T R A C T BackgroundAcute otitis media (AOM) is one of the most common childhood infectious diseases and a significant reason for antibiotic prescriptions in children worldwide. Pain from middle ear infection and pressure behind the eardrum is the key symptom of AOM. Ear pain is central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, analgesic treatment including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) is regarded as the cornerstone of AOM management in children. ObjectivesOur primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM. Our secondary objective was to assess the effectiveness of NSAIDs compared with paracetamol in children with AOM. Search methodsWe Selection criteriaWe included randomised controlled trials (RCTs) comparing the effectiveness of paracetamol or NSAIDs, alone or combined, for pain relief in children with AOM. We also included trials of paracetamol or NSAIDs, alone or combined, for children with fever or upper respiratory tract infections (URTIs) if we were able to extract subgroup data on pain relief in children with AOM either directly or after obtaining additional data from study authors. Data collection and analysisTwo review authors independently assessed methodological quality of the included trials and extracted data. We used the GRADE approach to rate the overall quality of evidence for each outcome of interest. Main resultsWe included three RCTs (327 children) which were assessed at low to moderate risk of bias.One RCT included 219 children with AOM, and used a three-arm, parallel group, double-blind design to compare paracetamol versus ibuprofen versus placebo. All children also received antibiotics and those with fever > 39°C could have received paracetamol (30 mg to 60 mg) additionally to the studied treatments.Another RCT involved 156 febrile children (26 of whom had AOM). The study design was a three-arm, parallel group, double-blind design and compared paracetamol versus ibuprofen versus ibuprofen plus paracetamol.The third RCT included 889 children with respiratory tract infections (82 of whom had AOM). This study applied a 3 x 2 x 2 factorial, open-label design and compared paracetamol versus ibuprofen versus ibuprofen plus paracetamol. Study participants were randomised to one of the three treatment groups as well as two dosing groups (regular versus as required) and two steam inhalation groups (steam versus no steam).Authors of two RCTs provided crude subgroup data on children with AOM. We used data from the remaining trial to inform comparison of paracetamol versus placebo (148 children) and ibuprofen versus placebo (146 children) assessments. Data from all included RCTs informed com...

Revisiting established medicines: An overview of systematic reviews about ibuprofen and paracetamol for treating pain in children

“…The 17 included SRs were published between 2004 and 2017. There were nine Cochrane SRs (Ashley, Parekh, Moles, Anand, & MacDonald, 2016;Brady-Fryer, Wiebe, & Lander, 2004;Cooper, Fisher, et al, 2017;Cooper, Heathcote, et al, 2017;Hobson, Wiffen, & Conlon, 2015;Lewis, Nicholson, Cardwell, Siviter, & Smith, 2013;Ohlsson & Shah, 2016;Sjoukes et al, 2016) and eight non-Cochrane SRs (Anand et al, 2005;Goldstein, Berlin, Berkovitch, & Kozer, 2008;Hamunen & Kontinen, 2005;Jenkins, Costello, & Hodge, 2004;Le May et al, 2016;Perrott, Piira, Goodenough, & Champion, 2004;Pierce & Voss, 2010;Southey, Soares-Weiser, & Kleijnen, 2009). Basic characteristics of included SRs are shown in Table 1 and more details about each of them in Supporting Information Table S3.…”

“…Seven SRs compared ibuprofen and paracetamol (Ashley et al, 2016;Lewis et al, 2013;Le May et al, 2016;Perrott et al, 2004;Pierce & Voss, 2010;Sjoukes et al, 2016;Southey et al, 2009); seven systematic reviews analysed only paracetamol (Anand et al, 2005;Brady-Fryer et al, 2004;Goldstein et al, 2008;Hamunen & Kontinen, 2005;Hobson et al, 2015;Jenkins et al, 2004;Ohlsson & Shah, 2016) and one SR analysed only ibuprofen . Three SRs analysed only safety, of paracetamol (Jenkins et al, 2004), ibuprofen (Lewis et al, 2013) or both ibuprofen and paracetamol (Southey et al, 2009).…”

“…We divided the analysed SRs into eight groups, according to the analysed indication: analgesia during invasive procedures in preterm infants and newborns (Anand et al, 2005;Brady-Fryer et al, 2004;Ohlsson & Shah, 2016), perioperative analgesia (Goldstein et al, 2008;Hamunen & Kontinen, 2005;Hobson et al, 2015;Lewis et al, 2013), analgesia in dental procedures (Ashley et al, 2016), analgesia in acute otitis media (AOM) (Sjoukes et al, 2016), analgesia in emergency department for acute musculoskeletal injuries (Le May et al, 2016), chronic non-cancer pain , cross-sensitivity of asthma caused by aspirin with non-opioid analgesics (Jenkins et al, 2004), and difference in effectiveness and safety between ibuprofen and paracetamol (Perrott et al, 2004;Pierce & Voss, 2010;Southey et al, 2009).…”

Safety Issues of Pharmacological Acute Pain Treatment in Children

“…There is very low quality evidence from randomized controlled trials that combination of analgesics is more effective than a single agent for pain relief in children, and none was large enough to draw firm conclusion regarding their safety. [98][99][100] Special attention should be paid because of the risks of dosage confusion and inappropriate dosing. It seems, therefore, reasonable to discontinue ibuprofen and acetaminophen therapy when prescribing opioids in children for moderate to severe pain.…”

What not to do in acute otitis media: the top five recommendations proposed by the Italian Society of Preventive and Social Pediatrics

“…Paracetamol or ibuprofen could be used (16,17,35,36). The use of anesthetic eardrops can be considered only in combination with systemic analgesic therapy, in case of moderate to severe otalgia, as they have the advantage of controlling pain more rapidly than systemic analgesics.…”