Acute otitis media in children Search date October 2013 Roderick P. Venekamp, Roger A.M.J. Damoiseaux, and Anne G.M. Schilder ABSTRACT INTRODUCTION: Acute otitis media (AOM) is a common reason for primary care visits in children. Yet, there is considerable debate on the most effective treatment. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments (analgesics, antibiotics, and myringotomy) in children with AOM? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2013 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 17 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: analgesics, antibiotics, delayed antibiotics, immediate antibiotics, longer courses of antibiotics, and myringotomy.
QUESTIONS What are the effects of treatments (analgesics, antibiotics, and myringotomy) in children with AOM?. . . . . . . . 3 INTERVENTIONS TREATMENTS FOR CHILDREN WITH AOM Likely to be beneficial Analgesics (paracetamol, NSAIDs, topical anaesthetic ear drops) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Trade off between benefits and harms Antibiotics (reduce symptoms more quickly than placebo but increase adverse effects) . . . . . . . . . . . . . . . . . . 6 Choice of antibiotic regimen . . . . . . . . . . . . . . . . . . . 9 Immediate compared with delayed antibiotic treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Longer versus shorter courses of antibiotics (reduce treatment failure in the short term but not the long term) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Likely to be ineffective or harmful Myringotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Covered elsewhere in Clinical Evidence See Chronic suppurative otitis media See Otitis media with effusion
Key points • Acute otitis media (AOM) is characterised by the presence of middle-ear effusion together with an acute onset of signs and symptoms caused by middle-ear inflammation. Middle-ear effusion without signs of an acute infection indicates otitis media with effusion (OME or 'glue ear'), while chronic suppurative otitis media (CSOM) is characterised by continuing (>3 months) middle-ear inflammation and ear discharge through tympanic membrane perforation or ventilation tubes (grommets). Interventions for these conditions are assessed in separate reviews in Clinical Evidence (see the reviews Otitis media with effusion in children and Chronic suppurative otitis media). The most common pathogens in AOM are Streptococcus pneumoniae, non-typeable Haemophilus influenzae, and Moraxella catarrhalis. Local resistance patterns are important when choosing the type of antibiotic. In the UK, antibiotics are prescribed for about 87% of AOM episodes in children's primary care visits. Without antibiotics, the clinical symptoms of AOM resolve in about 80% of children within 3 days. • Analgesics (paracetamol, non-steroidal anti-inflammatory drugs [NSAIDs], and topical anaesthetic drops) may reduce earache compared with placebo. • Antibiotics seem to reduce pain at 2 to 7 days compared with placebo, but they increase the risks of vomiting, diarrhoea, or rash. • We do not know whether any one antibiotic regimen should be used in preference to another, although amoxicillin may be more effective than macrolides and cephalosporin. • Immediate antibiotic use seems most beneficial in children aged under 2 years with bilateral AOM and in children with AOM presenting with ear discharge. Immediate antibiotic treatment may provide short-term reduction for some symptoms of AOM, but it increases the risk of rash and diarrhoea compared with delayed treatment. • Longer courses of antibiotics reduce short-term treatment failure but have no benefit in the longer term compared with shorter regimens (7 days or less). • Myringotomy may be less effective than antibiotics at reducing symptoms, and we found no evidence that it was superior to no myringotomy. © BMJ Publishing Group Ltd 2014. All rights reserved.
..................... 1 .....................
Clinical Evidence 2014;09:301
Child health
..................................................
Clinical context
GENERAL BACKGROUND Acute otitis media (AOM) is one of the most common infections in (early) childhood. It is defined as the presence of middle-ear effusion in conjunction with rapid onset of one or more signs or symptoms of inflammation of the middle ear such as fever, otalgia, and ear discharge (otorrhoea). Uncomplicated AOM is limited to the middle-ear cleft.
FOCUS OF THE REVIEW This review includes evidence on the effectiveness and safety of the following interventions for a single episode of acute otitis media: analgesics, short-courses of (delayed and immediate) antibiotics (in specific subgroups of children), longer courses of antibiotics, and myringotomy.
COMMENTS ON EVIDENCE Although analgesics are recognised as the cornerstone of treatment of AOM in children, we found only low-quality evidence on the effectiveness and safety of paracetamol, non-steroidal anti-inflammatory drugs, and topical anaesthetic ear drops. The quality of evidence regarding the effectiveness and safety of antibiotics was assessed as being of low to moderate using a GRADE evaluation. The quality of studies comparing different antibiotics with each other was judged to be very low.
SEARCH AND APPRAISAL SUMMARY The update literature search for this review was carried out from the date of the last search, September 2009, to October 2013. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the review, please see the Methods section. Searching of electronic databases retrieved 197 studies. After deduplication and removal of conference abstracts, 110 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 73 studies and the further review of 37 full publications. Of the 37 full articles evaluated, four systematic reviews and one RCT were included at this update.
ADDITIONAL INFORMATION Analgesics are likely to be beneficial in children with AOM but current evidence is of low-quality. The benefits and harms of antibiotic treatment should be carefully balanced, especially since AOM symptoms settle spontaneously within 3 days in 80% of children. Antibiotics seem most effective in children aged less than 2 years with bilateral AOM and in children with AOM presenting with ear discharge. DEFINITION
Otitis media, including acute otitis media (AOM) and otitis media with effusion (OME, also known as 'glue ear'), is one of the most common childhood conditions. While closely related, AOM and OME are two different, distinct conditions. AOM is characterised by the presence of middle-ear effusion together with an acute onset of signs and symptoms caused by middle ear inflammation. [1] Symptoms of AOM include earache in older children; or pulling, tugging, or rubbing of the ear or non-specific symptoms such as fever, irritability, or poor feeding in younger children. AOM signs [2] include a distinctly red, yellow, or cloudy tympanic membrane. AOM diagnosis is strengthened by the presence of a bulging tympanic membrane, an air-fluid level behind the tympanic membrane, [2] tympanic membrane perforation, and/or discharge in the ear canal. Pneumatic otoscopy and/or [3] tympanometry can be used to assess the presence (or absence) of middle ear effusion (MEE). In children with ventilation tubes (grommets) in place, ear discharge is a symptom of AOM whereby [4] fluid that has built up in the middle ear drains through the tube into the child's ear canal. Interventions for ear discharge associated with ventilation tubes are beyond the scope of this review. While most children have occasional AOM episodes, an important subset suffer from recurrent [5] AOM, defined as three or more episodes in 6 months or four episodes in 1 year. Middle ear effusion without signs of an acute infection indicates OME (see review on Otitis media with effusion), which can arise as a result of AOM, but can also occur independently. Chronic suppurative otitis media (CSOM, see review on CSOM) is characterised by continuing (>3 months) middle-ear inflammation and ear discharge through the tympanic membrane (perforation or ventilation tubes). Interventions for these conditions are assessed in separate reviews in Clinical Evidence (see review links above). For the purposes of this review, the age range used to define children is from birth to 15 years of age.
INCIDENCE/ PREVALENCE
AOM is one of the most common childhood infections and an important reason for primary care [6] [7] visits in the UK. In the UK, antibiotics are prescribed for 87% of these episodes.
AETIOLOGY/ The most common bacterial causes of AOM are Streptococcus pneumoniae, non-typeable [8] RISK FACTORS Haemophilus influenzae, and Moraxella catarrhalis. There is increasing evidence that the pre© BMJ Publishing Group Ltd 2014. All rights reserved.
........................................................... 2
Child health
Acute otitis media in children
dominant causative pathogen in AOM is changing from Streptococcus pneumoniae to non-typeable [8] Haemophilus influenzae since the introduction of pneumococcal conjugate vaccines. Group childcare outside the home and passive smoking are thought to be the most important risk factors [9] for AOM. Other risk factors include pacifier use and positive family history of AOM. Breastfeeding [9] for 3 months or longer has a protective effect. PROGNOSIS
Without antibiotic treatment, AOM symptoms improve in 24 hours in 60% of children, and symptoms [10] settle spontaneously within 3 days in 80% of children. Serious complications of AOM include [10] acute mastoiditis, meningitis, and, rarely, intracranial complications. If antibiotics are withheld, [11] acute mastoiditis occurs in about 1 to 2 per 10,000 children.
AIMS OF To reduce the severity and duration of pain and other AOM-related symptoms; to prevent compliINTERVENTION cations; to minimise adverse effects of treatment. OUTCOMES
Symptoms of AOM (including earache [which can be assessed in young children by surrogate measures such as parental observation of distress/crying and analgesic use] and fever); recurrence of infection; complications of infection (including acute mastoiditis, meningitis, intracranial complications, and hearing problems due to middle-ear fluid [which can be assessed by surrogate measures such as abnormal tympanometry findings]), adverse effects.
METHODS
Clinical Evidence search and appraisal October 2013. The following databases were used to identify studies for this systematic review: Medline 1966 to October 2013, Embase 1980 to October 2013, and The Cochrane Database of Systematic Reviews 2013, issue 9 (online; 1966 to date of issue). Additional searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA) Database. We also searched for retractions of studies included in the review. Titles and abstracts identified by the initial search, run by an information specialist, were assessed against predefined criteria by an evidence analyst. Studies selected for inclusion were discussed with an expert contributor. All data relevant to the review were then extracted by an evidence analyst. Study design criteria for inclusion in this review were: published RCTs and systematic reviews of RCTs, at least single-blinded and containing more than 20 individuals, of whom more than 80% were followed up. There was no minimum length of followup. We excluded all studies described as 'open', 'open label', or not blinded, unless blinding was impossible. We included RCTs and systematic reviews of RCTs where harms of an included intervention were assessed, applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table, p 21 ). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest.These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
QUESTION
What are the effects of treatments (analgesics, antibiotics, and myringotomy) in children with AOM?
OPTION
ANALGESICS (PARACETAMOL, NSAIDS, TOPICAL ANAESTHETIC EAR DROPS). . . . . . . . .
•
For GRADE evaluation of interventions for Acute otitis media in children, see table, p 21 .
•
Analgesics (paracetamol, non-steroidal anti-inflammatory drugs [NSAIDs], and topical anaesthetic ear drops) may reduce earache compared with placebo. Benefits and harms
Topical anaesthetic drops versus placebo: [12] We found one systematic review (search date 2011, 2 RCTs). -
© BMJ Publishing Group Ltd 2014. All rights reserved.
...........................................................
3
Child health
Acute otitis media in children
Symptoms of AOM Topical anaesthetic drops compared with placebo Topical anaesthetic drops may be more effective at reducing earache 10 to 30 minutes after administration in children taking paracetamol (low-quality evidence). Ref (type)
Population
Outcome, Interventions
117 people, aged 3–19 years
25% reduction in earache , 10 minutes after administration
2 RCTs in this analysis
37/58 (64%) with topical anaesthetic drops
Results and statistical analysis
Effect size
Favours
Pain [12]
Systematic review
25/59 (42%) with placebo All participants also received paracetamol
RR 1.51 95% CI 1.06 to 2.15 P = 0.02 NNT 4 95% CI 3 to 27
topical anaesthetic drops
See Further information on studies for full details of co-interventions [12]
Systematic review
117 people, aged 3–19 years
25% reduction in earache , 20 minutes after administration
2 RCTs in this analysis
46/58 (79%) with topical anaesthetic drops 35/59 (59%) with placebo All participants also received paracetamol
[12]
Systematic review
117 people, aged 3–19 years
25% reduction in earache , 30 minutes after administration
2 RCTs in this analysis
54/58 (93%) with topical anaesthetic drops 41/59 (69%) with placebo All participants also received paracetamol
[12]
Systematic review
117 people, aged 3–19 years
50% reduction in earache , 10 minutes after administration
2 RCTs in this analysis
25/58 (43%) with topical anaesthetic drops 12/59 (20%) with placebo All participants also received paracetamol
[12]
Systematic review
117 people, aged 3–19 years
50% reduction in earache , 20 minutes after administration
2 RCTs in this analysis
34/58 (59%) with topical anaesthetic drops
RR 1.34 95% CI 1.04 to 1.71 P = 0.02 NNT 5
topical anaesthetic drops
95% CI 3 to 27
RR 1.34 95% CI 1.12 to 1.61 P
QUESTIONS What are the effects of treatments (analgesics, antibiotics, and myringotomy) in children with AOM?. . . . . . . . 3 INTERVENTIONS TREATMENTS FOR CHILDREN WITH AOM Likely to be beneficial Analgesics (paracetamol, NSAIDs, topical anaesthetic ear drops) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Trade off between benefits and harms Antibiotics (reduce symptoms more quickly than placebo but increase adverse effects) . . . . . . . . . . . . . . . . . . 6 Choice of antibiotic regimen . . . . . . . . . . . . . . . . . . . 9 Immediate compared with delayed antibiotic treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Longer versus shorter courses of antibiotics (reduce treatment failure in the short term but not the long term) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Likely to be ineffective or harmful Myringotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Covered elsewhere in Clinical Evidence See Chronic suppurative otitis media See Otitis media with effusion
Key points • Acute otitis media (AOM) is characterised by the presence of middle-ear effusion together with an acute onset of signs and symptoms caused by middle-ear inflammation. Middle-ear effusion without signs of an acute infection indicates otitis media with effusion (OME or 'glue ear'), while chronic suppurative otitis media (CSOM) is characterised by continuing (>3 months) middle-ear inflammation and ear discharge through tympanic membrane perforation or ventilation tubes (grommets). Interventions for these conditions are assessed in separate reviews in Clinical Evidence (see the reviews Otitis media with effusion in children and Chronic suppurative otitis media). The most common pathogens in AOM are Streptococcus pneumoniae, non-typeable Haemophilus influenzae, and Moraxella catarrhalis. Local resistance patterns are important when choosing the type of antibiotic. In the UK, antibiotics are prescribed for about 87% of AOM episodes in children's primary care visits. Without antibiotics, the clinical symptoms of AOM resolve in about 80% of children within 3 days. • Analgesics (paracetamol, non-steroidal anti-inflammatory drugs [NSAIDs], and topical anaesthetic drops) may reduce earache compared with placebo. • Antibiotics seem to reduce pain at 2 to 7 days compared with placebo, but they increase the risks of vomiting, diarrhoea, or rash. • We do not know whether any one antibiotic regimen should be used in preference to another, although amoxicillin may be more effective than macrolides and cephalosporin. • Immediate antibiotic use seems most beneficial in children aged under 2 years with bilateral AOM and in children with AOM presenting with ear discharge. Immediate antibiotic treatment may provide short-term reduction for some symptoms of AOM, but it increases the risk of rash and diarrhoea compared with delayed treatment. • Longer courses of antibiotics reduce short-term treatment failure but have no benefit in the longer term compared with shorter regimens (7 days or less). • Myringotomy may be less effective than antibiotics at reducing symptoms, and we found no evidence that it was superior to no myringotomy. © BMJ Publishing Group Ltd 2014. All rights reserved.
..................... 1 .....................
Clinical Evidence 2014;09:301
Child health
..................................................
Clinical context
GENERAL BACKGROUND Acute otitis media (AOM) is one of the most common infections in (early) childhood. It is defined as the presence of middle-ear effusion in conjunction with rapid onset of one or more signs or symptoms of inflammation of the middle ear such as fever, otalgia, and ear discharge (otorrhoea). Uncomplicated AOM is limited to the middle-ear cleft.
FOCUS OF THE REVIEW This review includes evidence on the effectiveness and safety of the following interventions for a single episode of acute otitis media: analgesics, short-courses of (delayed and immediate) antibiotics (in specific subgroups of children), longer courses of antibiotics, and myringotomy.
COMMENTS ON EVIDENCE Although analgesics are recognised as the cornerstone of treatment of AOM in children, we found only low-quality evidence on the effectiveness and safety of paracetamol, non-steroidal anti-inflammatory drugs, and topical anaesthetic ear drops. The quality of evidence regarding the effectiveness and safety of antibiotics was assessed as being of low to moderate using a GRADE evaluation. The quality of studies comparing different antibiotics with each other was judged to be very low.
SEARCH AND APPRAISAL SUMMARY The update literature search for this review was carried out from the date of the last search, September 2009, to October 2013. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the review, please see the Methods section. Searching of electronic databases retrieved 197 studies. After deduplication and removal of conference abstracts, 110 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 73 studies and the further review of 37 full publications. Of the 37 full articles evaluated, four systematic reviews and one RCT were included at this update.
ADDITIONAL INFORMATION Analgesics are likely to be beneficial in children with AOM but current evidence is of low-quality. The benefits and harms of antibiotic treatment should be carefully balanced, especially since AOM symptoms settle spontaneously within 3 days in 80% of children. Antibiotics seem most effective in children aged less than 2 years with bilateral AOM and in children with AOM presenting with ear discharge. DEFINITION
Otitis media, including acute otitis media (AOM) and otitis media with effusion (OME, also known as 'glue ear'), is one of the most common childhood conditions. While closely related, AOM and OME are two different, distinct conditions. AOM is characterised by the presence of middle-ear effusion together with an acute onset of signs and symptoms caused by middle ear inflammation. [1] Symptoms of AOM include earache in older children; or pulling, tugging, or rubbing of the ear or non-specific symptoms such as fever, irritability, or poor feeding in younger children. AOM signs [2] include a distinctly red, yellow, or cloudy tympanic membrane. AOM diagnosis is strengthened by the presence of a bulging tympanic membrane, an air-fluid level behind the tympanic membrane, [2] tympanic membrane perforation, and/or discharge in the ear canal. Pneumatic otoscopy and/or [3] tympanometry can be used to assess the presence (or absence) of middle ear effusion (MEE). In children with ventilation tubes (grommets) in place, ear discharge is a symptom of AOM whereby [4] fluid that has built up in the middle ear drains through the tube into the child's ear canal. Interventions for ear discharge associated with ventilation tubes are beyond the scope of this review. While most children have occasional AOM episodes, an important subset suffer from recurrent [5] AOM, defined as three or more episodes in 6 months or four episodes in 1 year. Middle ear effusion without signs of an acute infection indicates OME (see review on Otitis media with effusion), which can arise as a result of AOM, but can also occur independently. Chronic suppurative otitis media (CSOM, see review on CSOM) is characterised by continuing (>3 months) middle-ear inflammation and ear discharge through the tympanic membrane (perforation or ventilation tubes). Interventions for these conditions are assessed in separate reviews in Clinical Evidence (see review links above). For the purposes of this review, the age range used to define children is from birth to 15 years of age.
INCIDENCE/ PREVALENCE
AOM is one of the most common childhood infections and an important reason for primary care [6] [7] visits in the UK. In the UK, antibiotics are prescribed for 87% of these episodes.
AETIOLOGY/ The most common bacterial causes of AOM are Streptococcus pneumoniae, non-typeable [8] RISK FACTORS Haemophilus influenzae, and Moraxella catarrhalis. There is increasing evidence that the pre© BMJ Publishing Group Ltd 2014. All rights reserved.
........................................................... 2
Child health
Acute otitis media in children
dominant causative pathogen in AOM is changing from Streptococcus pneumoniae to non-typeable [8] Haemophilus influenzae since the introduction of pneumococcal conjugate vaccines. Group childcare outside the home and passive smoking are thought to be the most important risk factors [9] for AOM. Other risk factors include pacifier use and positive family history of AOM. Breastfeeding [9] for 3 months or longer has a protective effect. PROGNOSIS
Without antibiotic treatment, AOM symptoms improve in 24 hours in 60% of children, and symptoms [10] settle spontaneously within 3 days in 80% of children. Serious complications of AOM include [10] acute mastoiditis, meningitis, and, rarely, intracranial complications. If antibiotics are withheld, [11] acute mastoiditis occurs in about 1 to 2 per 10,000 children.
AIMS OF To reduce the severity and duration of pain and other AOM-related symptoms; to prevent compliINTERVENTION cations; to minimise adverse effects of treatment. OUTCOMES
Symptoms of AOM (including earache [which can be assessed in young children by surrogate measures such as parental observation of distress/crying and analgesic use] and fever); recurrence of infection; complications of infection (including acute mastoiditis, meningitis, intracranial complications, and hearing problems due to middle-ear fluid [which can be assessed by surrogate measures such as abnormal tympanometry findings]), adverse effects.
METHODS
Clinical Evidence search and appraisal October 2013. The following databases were used to identify studies for this systematic review: Medline 1966 to October 2013, Embase 1980 to October 2013, and The Cochrane Database of Systematic Reviews 2013, issue 9 (online; 1966 to date of issue). Additional searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA) Database. We also searched for retractions of studies included in the review. Titles and abstracts identified by the initial search, run by an information specialist, were assessed against predefined criteria by an evidence analyst. Studies selected for inclusion were discussed with an expert contributor. All data relevant to the review were then extracted by an evidence analyst. Study design criteria for inclusion in this review were: published RCTs and systematic reviews of RCTs, at least single-blinded and containing more than 20 individuals, of whom more than 80% were followed up. There was no minimum length of followup. We excluded all studies described as 'open', 'open label', or not blinded, unless blinding was impossible. We included RCTs and systematic reviews of RCTs where harms of an included intervention were assessed, applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table, p 21 ). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest.These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
QUESTION
What are the effects of treatments (analgesics, antibiotics, and myringotomy) in children with AOM?
OPTION
ANALGESICS (PARACETAMOL, NSAIDS, TOPICAL ANAESTHETIC EAR DROPS). . . . . . . . .
•
For GRADE evaluation of interventions for Acute otitis media in children, see table, p 21 .
•
Analgesics (paracetamol, non-steroidal anti-inflammatory drugs [NSAIDs], and topical anaesthetic ear drops) may reduce earache compared with placebo. Benefits and harms
Topical anaesthetic drops versus placebo: [12] We found one systematic review (search date 2011, 2 RCTs). -
© BMJ Publishing Group Ltd 2014. All rights reserved.
...........................................................
3
Child health
Acute otitis media in children
Symptoms of AOM Topical anaesthetic drops compared with placebo Topical anaesthetic drops may be more effective at reducing earache 10 to 30 minutes after administration in children taking paracetamol (low-quality evidence). Ref (type)
Population
Outcome, Interventions
117 people, aged 3–19 years
25% reduction in earache , 10 minutes after administration
2 RCTs in this analysis
37/58 (64%) with topical anaesthetic drops
Results and statistical analysis
Effect size
Favours
Pain [12]
Systematic review
25/59 (42%) with placebo All participants also received paracetamol
RR 1.51 95% CI 1.06 to 2.15 P = 0.02 NNT 4 95% CI 3 to 27
topical anaesthetic drops
See Further information on studies for full details of co-interventions [12]
Systematic review
117 people, aged 3–19 years
25% reduction in earache , 20 minutes after administration
2 RCTs in this analysis
46/58 (79%) with topical anaesthetic drops 35/59 (59%) with placebo All participants also received paracetamol
[12]
Systematic review
117 people, aged 3–19 years
25% reduction in earache , 30 minutes after administration
2 RCTs in this analysis
54/58 (93%) with topical anaesthetic drops 41/59 (69%) with placebo All participants also received paracetamol
[12]
Systematic review
117 people, aged 3–19 years
50% reduction in earache , 10 minutes after administration
2 RCTs in this analysis
25/58 (43%) with topical anaesthetic drops 12/59 (20%) with placebo All participants also received paracetamol
[12]
Systematic review
117 people, aged 3–19 years
50% reduction in earache , 20 minutes after administration
2 RCTs in this analysis
34/58 (59%) with topical anaesthetic drops
RR 1.34 95% CI 1.04 to 1.71 P = 0.02 NNT 5
topical anaesthetic drops
95% CI 3 to 27
RR 1.34 95% CI 1.12 to 1.61 P
