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

Alies Sjoukes; Roderick P Venekamp; Alma C van de Pol; Alastair D Hay; Paul Little; Anne GM Schilder; Roger AMJ Damoiseaux

doi:10.1002/14651858.CD011534.pub2

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Figure 1

Study flow diagram

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Figure 4

Forest plot of comparison: 1 Paracetamol versus placebo, outcome: 1.1 Pain at 48 hours

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Figure 5

Forest plot of comparison: 2 NSAIDs versus placebo, outcome: 2.1 Pain at 48 hours

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Figure 6

Forest plot of comparison: 3 NSAIDs versus paracetamol, outcome: 3.2 Pain at 48 to 72 hours

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Analysis 1.1

Comparison 1 Paracetamol versus placebo, Outcome 1 Pain at 48 hours.

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Analysis 1.2

Comparison 1 Paracetamol versus placebo, Outcome 2 Adverse events.

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Analysis 1.3

Comparison 1 Paracetamol versus placebo, Outcome 3 Fever at 48 hours.

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Analysis 2.1

Comparison 2 NSAIDs versus placebo, Outcome 1 Pain at 48 hours.

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Analysis 2.2

Comparison 2 NSAIDs versus placebo, Outcome 2 Adverse events.

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Analysis 2.3

Comparison 2 NSAIDs versus placebo, Outcome 3 Fever at 48 hours.

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Analysis 3.1

Comparison 3 NSAIDs versus paracetamol, Outcome 1 Pain at 24 hours.

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Analysis 3.2

Comparison 3 NSAIDs versus paracetamol, Outcome 2 Pain at 48 to 72 hours.

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Analysis 3.3

Comparison 3 NSAIDs versus paracetamol, Outcome 3 Pain at 4 to 7 days.

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Analysis 3.4

Comparison 3 NSAIDs versus paracetamol, Outcome 4 Adverse events.

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Analysis 3.5

Comparison 3 NSAIDs versus paracetamol, Outcome 5 Mild pain at 24 hours.

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Analysis 3.6

Comparison 3 NSAIDs versus paracetamol, Outcome 6 Mild pain at 48 to 72 hours.

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Analysis 3.7

Comparison 3 NSAIDs versus paracetamol, Outcome 7 Mild pain at 4 to 7 days.

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Analysis 3.8

Comparison 3 NSAIDs versus paracetamol, Outcome 8 Mean pain score at 24 hours.

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Analysis 3.9

Comparison 3 NSAIDs versus paracetamol, Outcome 9 Mean pain score at 48 to 72 hours.

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Analysis 3.10

Comparison 3 NSAIDs versus paracetamol, Outcome 10 Mean pain score at 4 to 7 days.

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Analysis 3.11

Comparison 3 NSAIDs versus paracetamol, Outcome 11 Fever at 24 hours.

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Analysis 3.12

Comparison 3 NSAIDs versus paracetamol, Outcome 12 Fever at 48 to 72 hours.

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Analysis 3.13

Comparison 3 NSAIDs versus paracetamol, Outcome 13 Fever at 4 to 7 days.

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Analysis 3.14

Comparison 3 NSAIDs versus paracetamol, Outcome 14 Re‐consultations.

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Analysis 3.15

Comparison 3 NSAIDs versus paracetamol, Outcome 15 Delayed antibiotic prescriptions.

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Analysis 4.1

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 1 Pain at 24 hours.

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Analysis 4.2

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 2 Pain at 48 to 72 hours.

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Analysis 4.3

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 3 Pain at 4 to 7 days.

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Analysis 4.4

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 4 Adverse events.

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Analysis 4.5

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 5 Mild pain at 24 hours.

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Analysis 4.6

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 6 Mild pain at 48 to 72 hours.

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Analysis 4.7

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 7 Mild pain at 4 to 7 days.

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Analysis 4.8

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 8 Mean pain at 24 hours.

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Analysis 4.9

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 9 Mean pain at 48 to 72 hours.

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Analysis 4.10

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 10 Mean pain at 4 to 7 days.

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Analysis 4.11

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 11 Fever at 24 hours.

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Analysis 4.12

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 12 Fever at 48 to 72 hours.

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Analysis 4.13

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 13 Fever at 4 to 7 days.

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Analysis 4.14

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 14 Re‐consultations.

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Analysis 4.15

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 15 Delayed antibiotic prescriptions.

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Analysis 4.16

Comparison 4 NSAIDs + paracetamol versus paracetamol, Outcome 16 Serious complications.

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Summary of findings for the main comparison. Paracetamol versus placebo for acute otitis media in children

Paracetamol versus placebo for acute otitis media in children
Patients: children with acute otitis media Setting: outpatients in four centres Intervention: paracetamol Control: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with paracetamol
Pain at various time points
24 hours	no data available		n/a	n/a	n/a
48 to 72 hours (48 hours)	Study population		RR 0.38 (0.17 to 0.85)	148 (1 RCT)	⊕⊕⊝⊝ low¹	NNTB based on the study population risk was 1/(253 to 96)*1000 = 7
	253 per 1000	96 per 1000 (43 to 215)
4 to 7 days	no data available
Adverse events	Study population		RR 1.03 (0.21 to 4.93)	148 (1 RCT)	⊕⊝⊝⊝ very low²
	40 per 1000	41 per 1000 (8 to 197)
Mean time to resolution of pain	no data available		n/a	n/a	n/a
Mean pain score at various time points	no data available		n/a	n/a	n/a
Fever at various time points
24 hours	no data available		n/a	n/a	n/a
48 to 72 hours (48 hours)	Study population		RR 1.03 (0.07 to 16.12)	148 (1 RCT)	⊕⊝⊝⊝ very low³
	13 per 1000	14 per 1000 (1 to 215)
4 to 7 days	no data available		n/a	n/a	n/a
Re‐consultations	no data available		n/a	n/a	n/a
Delayed antibiotic prescriptions	no data available		n/a	n/a	n/a
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; NNTB: number needed to treat to benefit; RR: Risk ratio; RCT: randomised controlled trial;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ We downgraded the evidence from high to low quality due to study limitations and questions about the applicability of evidence. ² We downgraded the evidence from high to very low quality due to study limitations and imprecise effect estimate (small sample size and infrequent occurrence of the outcome). ³ We downgraded the evidence from high to very low quality due to study limitations, imprecise effect estimate (infrequent occurrence of the outcome) and questions about the applicability of evidence.

Summary of findings for the main comparison. Paracetamol versus placebo for acute otitis media in children

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Summary of findings 2. NSAIDs versus placebo for acute otitis media in children

NSAIDs versus placebo for acute otitis media in children
Patients: children with acute otitis media Setting: outpatients in four centres Intervention: ibuprofen Control: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with ibuprofen
Pain at various time points
24 hours	no data available		n/a	n/a	n/a
48 to 72 hours (48 hours)	Study population		RR 0.28 (0.11 to 0.70)	146 (1 RCT)	⊕⊕⊝⊝ low¹	NNTB based on the study population risk was 1/(253 to 71)*1000 = 6
	253 per 1000	71 per 1000 (28 to 177)
4 to 7 days	no data available		n/a	n/a	n/a
Adverse events	Study population		RR 1.76 (0.44 to 7.10)	146 (1 RCT)	⊕⊝⊝⊝ very low²
	40 per 1000	70 per 1000 (18 to 284)
Mean time to resolution of pain	no data available		n/a	n/a	n/a
Mean pain score at various time points	no data available		n/a	n/a	n/a
Fever at various time points
24 hours	no data available		n/a	n/a	n/a
48 to 72 hours (48 hours)	Study population		RR 1.06 (0.07 to 16.57)	146 (1 RCT)	⊕⊝⊝⊝ very low³
	13 per 1000	14 per 1000 (1 to 221)
4 to 7 days	no data available		n/a	n/a	n/a
Re‐consultations	no data available		n/a	n/a	n/a
Delayed antibiotic prescriptions	no data available		n/a	n/a	n/a
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; NNTB: number needed to treat to benefit; RR: Risk ratio; RCT: randomised controlled trial;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ We downgraded the evidence from high to low quality due to study limitations and questions about the applicability of evidence. ² We downgraded the evidence from high to very low quality due to study limitations and imprecise effect estimate (small sample size and infrequent occurrence of the outcome). ³ We downgraded the evidence from high to very low quality due to study limitations, imprecise effect estimate (infrequent occurrence of the outcome) and questions about the applicability of evidence.

Summary of findings 2. NSAIDs versus placebo for acute otitis media in children

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Summary of findings 3. NSAIDs versus paracetamol for acute otitis media in children

NSAIDs versus paracetamol for acute otitis media in children
Patients: children with acute otitis media Setting: community, primary care, secondary care Intervention: ibuprofen Control: paracetamol
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with paracetamol	Risk with ibuprofen
Pain at various time points
24 hours	Study population		RR 0.83 (0.59 to 1.18)	39 (2 RCTs)	⊕⊝⊝⊝ very low¹
	778 per 1000	646 per 1000 (459 to 918)
48 to 72 hours	Study population		RR 0.91 (0.54 to 1.54)	183 (3 RCTs)	⊕⊕⊝⊝ low²
	178 per 1000	162 per 1000 (96 to 274)
4 to 7 days	Study population		RR 0.74 (0.17 to 3.23)	38 (2 RCTs)	⊕⊝⊝⊝ very low¹
	188 per 1000	139 per 1000 (32 to 606)
Adverse events	Study population		RR 1.71 (0.43 to 6.90)	197 (2 RCTs)	⊕⊝⊝⊝ very low³
	30 per 1000	51 per 1000 (13 to 207)
Mean time to resolution of pain	no data available		n/a	n/a	n/a
Mean pain score at various time points**
24 hours	The mean pain score with ibuprofen ranged from 2.5 to 3.9	The mean pain score with paracetamol was on average 0.10 lower (0.67 lower to 0.47 higher)	n/a	39 (2 RCTs)	⊕⊝⊝⊝ very low¹
48 to 72 hours	The mean pain score with ibuprofen ranged from 1.6 to 2.4	The mean pain score with paracetamol was on average 0.19 lower (0.65 lower to 0.27 higher)	n/a	39 (2 RCTs)	⊕⊝⊝⊝ very low¹
4 to 7 days	The mean pain score with ibuprofen ranged from 1 to 2.2	The mean pain score with paracetamol was on average 0.30 higher (1.78 lower to 2.38 higher)	n/a	31 (2 RCTs)	⊕⊝⊝⊝ very low¹
Fever at various time points
24 hours	Study population		RR 0.69 (0.24 to 2.00)	39 (2 RCTs)	⊕⊝⊝⊝ very low¹
	294 per 1000	203 per 1000 (71 to 588)
48 to 72 hours	Study population		RR 1.18 (0.31 to 4.44)	182 (3 RCTs)	⊕⊕⊝⊝ low²
	33 per 1000	39 per 1000 (10 to 148)
4 to 7 days	Study population		RR 2.75 (0.12 to 60.70)	39 (2 RCTs)	⊕⊝⊝⊝ very low¹
	0 per 1000	0 per 1000 (0 to 0)
Re‐consultations	Study population		RR 1.13 (0.92 to 1.40)	53 (1 RCT)	⊕⊝⊝⊝ very low¹
	815 per 1000	921 per 1000 (750 to 1.000)
Delayed antibiotic prescriptions	Study population		RR 1.32 (0.74 to 2.35)	53 (1 RCT)	⊕⊝⊝⊝ very low¹
	407 per 1000	538 per 1000 (301 to 957)
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Hay 2009 assessed fever‐associated discomfort using a validated comfort scale (no comfort; not quite normal; some pain/distress; crying/very distressed), whereas Little 2013 assessed ear pain using a validated symptom score (ranging from 0 to 6 with 0 = no problem and 6 = as bad as it could be). CI: Confidence interval; NNTB: number needed to treat to benefit; RR: Risk ratio; RCT:** randomised controlled trial;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ We downgraded the evidence high to very low quality due to study limitations and imprecise effect estimate (very small sample size). ² We downgraded the evidence from high to low quality due to study limitations and questions about the applicability of evidence. ³ We downgraded the evidence from high to very low quality due to study limitations and imprecise effect estimate (small sample size and infrequent occurrence of the outcome).

Summary of findings 3. NSAIDs versus paracetamol for acute otitis media in children

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Comparison 1. Paracetamol versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 48 hours Show forest plot	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.17, 0.85]

2 Adverse events Show forest plot	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.21, 4.93]

3 Fever at 48 hours Show forest plot	1	148	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.07, 16.12]

Comparison 1. Paracetamol versus placebo

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Comparison 2. NSAIDs versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 48 hours Show forest plot	1	146	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.11, 0.70]

2 Adverse events Show forest plot	1	146	Risk Ratio (M‐H, Fixed, 95% CI)	1.76 [0.44, 7.10]

3 Fever at 48 hours Show forest plot	1	146	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.07, 16.57]

Comparison 2. NSAIDs versus placebo

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Comparison 3. NSAIDs versus paracetamol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 24 hours Show forest plot	2	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.59, 1.18]

2 Pain at 48 to 72 hours Show forest plot	3	183	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.54, 1.54]

3 Pain at 4 to 7 days Show forest plot	2	38	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.17, 3.23]

4 Adverse events Show forest plot	2	197	Risk Ratio (M‐H, Random, 95% CI)	1.71 [0.43, 6.90]

5 Mild pain at 24 hours Show forest plot	2	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.31, 3.73]

6 Mild pain at 48 to 72 hours Show forest plot	2	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.35 [0.62, 2.91]

7 Mild pain at 4 to 7 days Show forest plot	2	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.37, 2.23]

8 Mean pain score at 24 hours Show forest plot	2	39	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.47, 0.67]

9 Mean pain score at 48 to 72 hours Show forest plot	2	39	Mean Difference (IV, Fixed, 95% CI)	0.19 [‐0.27, 0.65]

10 Mean pain score at 4 to 7 days Show forest plot	2	31	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐2.38, 1.78]

11 Fever at 24 hours Show forest plot	2	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.24, 2.00]

12 Fever at 48 to 72 hours Show forest plot	3	182	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.31, 4.44]

13 Fever at 4 to 7 days Show forest plot	2	39	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [0.12, 60.70]

14 Re‐consultations Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.92, 1.40]

15 Delayed antibiotic prescriptions Show forest plot	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.74, 2.35]

Comparison 3. NSAIDs versus paracetamol

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Comparison 4. NSAIDs + paracetamol versus paracetamol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 24 hours Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.78, 1.47]

2 Pain at 48 to 72 hours Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.42, 1.20]

3 Pain at 4 to 7 days Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	1.65 [0.58, 4.72]

4 Adverse events Show forest plot	1	56	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

5 Mild pain at 24 hours Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.02, 1.74]

6 Mild pain at 48 to 72 hours Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.24, 1.62]

7 Mild pain at 4 to 7 days Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.17, 1.43]

8 Mean pain at 24 hours Show forest plot	2	40	Mean Difference (IV, Random, 95% CI)	0.32 [‐0.59, 1.23]

9 Mean pain at 48 to 72 hours Show forest plot	2	40	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐0.77, 1.97]

10 Mean pain at 4 to 7 days Show forest plot	2	33	Mean Difference (IV, Fixed, 95% CI)	0.7 [‐1.01, 2.41]

11 Fever at 24 hours Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [0.73, 2.99]

12 Fever at 48 to 72 hours Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	2.13 [0.60, 7.60]

13 Fever at 4 to 7 days Show forest plot	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

14 Re‐consultations Show forest plot	1	56	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.58, 1.11]

15 Delayed antibiotic prescriptions Show forest plot	1	56	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.71, 2.26]

16 Serious complications Show forest plot	2	71	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. NSAIDs + paracetamol versus paracetamol

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