Diclofenac for acute pain in children

Joseph F Standing; Imogen Savage; Deborah Pritchard; Marina Waddington

doi:10.1002/14651858.CD005538.pub2

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Figure 1

Forest plot of comparison: 1 Diclofenac vs no treatment/placebo, outcome: 1.1 Number of patients requiring rescue analgesia.

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Figure 2

Forest plot of comparison: 2 Diclofenac vs paracetamol, outcome: 2.1 Number of patients requiring rescue analgesia.

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Figure 3

Forest plot of comparison: 3 Diclofenac vs any other treatment, outcome: 3.1 Nausea and/or vomiting.

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Figure 4

Forest plot of comparison: 3 Diclofenac vs any other treatment, outcome: 3.2 Bleeding requiring surgical intervention.

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Figure 5

Forest plot of comparison: 4 Diclofenac vs other NSAIDs, outcome: 4.1 Nausea and/or vomiting.

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Analysis 1.1

Comparison 1 Diclofenac vs no treatment/placebo, Outcome 1 Number of patients requiring rescue analgesia.

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Analysis 2.1

Comparison 2 Diclofenac vs paracetamol, Outcome 1 Number of patients requiring rescue analgesia.

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Analysis 3.1

Comparison 3 Diclofenac vs any other treatment, Outcome 1 Nausea and/or vomiting.

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Analysis 3.2

Comparison 3 Diclofenac vs any other treatment, Outcome 2 Bleeding requiring surgical intervention.

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Analysis 4.1

Comparison 4 Diclofenac vs other NSAIDs, Outcome 1 Nausea and/or vomiting.

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Analysis 4.2

Comparison 4 Diclofenac vs other NSAIDs, Outcome 2 Bleeding requiring surgical intervention.

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Table 1. Quality analysis of safety study papers

Quality categories	High	Moderate	Low
Study design	Prospective, number of patients exposed to diclofenac given	Prospective, number of patients exposed to diclofenac given	Prospective or retrospective, number of patients exposed to diclofenac given
Adverse event monitoring	Evidence of monitoring for adverse events	Evidence of monitoring for adverse events	Spontaneous reporting of adverse events
Adverse event reporting	Specific adverse events reported	Adverse events may be grouped by system	Adverse events may be grouped by system
Assessment of causality linking adverse events and adverse drug reactions	Use of causality algorithm or difference versus placebo in double‐blind RCT	Causality may be attributed by clinical judgement or difference versus placebo in double‐blind RCT	Causality may be attributed by clinical judgement or difference versus placebo in double‐blind RCT
Follow‐up	Post‐discharge follow‐up on at least one occasion	No evidence of follow‐up	No evidence of follow‐up

Table 1. Quality analysis of safety study papers

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Table 2. Serious adverse events in 3611 participants given diclofenac for acute pain

Study	Number of Events	Description
Duarte 1997*	1	Palpebral oedema "of serious intensity". Diclofenac stopped
Fischer 1992	1	Unclear as refers to table grouping moderate/severe as rated by patient. Reaction is one of: vomiting, headache, stomach pain or erythema.
Kierszenbaum 1991*	2	Hypothermia "obliging the suspension of treatment"
Kokinsky 1999	1	Protracted vomiting requiring prolonged hospitalisation.
Kokinsky 1999	1	Bleeding after penile surgery requiring re‐operation.
Leontev 2005	5	Allergic skin reaction, reversed with injected chlorpyramine
McGowan 1998	2	Late haemorrhage after day‐case circumcision requiring hospital admission.
Mendham 1996	3	Haemorrhage after tonsillectomy requiring re‐operation.
Oztekin 2002	1	Bleeding after tonsillectomy requiring prolonged hospitalisation.
Tawalbeh 2001	1	Bleeding requiring re‐hospitalisation after tonsillectomy.
Tewary 1993	6	Bleeding causing prolonged or re‐hospitalisation after tonsillectomy.
Thiagarajan 1993	1	Bleeding requiring re‐operation after tonsillectomy.
Vuori 2004	1	Bleeding requiring blood transfusion following major surgery.
TOTAL	26	NOTE: Only two studies * reported that they considered these serious adverse events to be adverse drug reactions caused by diclofenac.

Table 2. Serious adverse events in 3611 participants given diclofenac for acute pain

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Table 3. Summary of case reports sorted by indication

Reaction type	Chronic treatment	Indication unknown	Acute pain
Acute allergic‐type reaction	0	1	4
Cardiovascular	0	0	1
Central nervous system	5	2	5
Dermatological	7	4	3
Endocrine	1	1	0
Genitourinary	3	0	1
Gastrointestinal ‐ bleeding	3	3	7
Gastrointestinal ‐ general	3	1	5
Haematological	1	0	5
Hepatic	2	0	0
Injection site reactions	0	0	6
Muscular	0	0	2
Renal	0	1	0
Respiratory	4	1	3

Table 3. Summary of case reports sorted by indication

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Comparison 1. Diclofenac vs no treatment/placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients requiring rescue analgesia Show forest plot	5	239	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.47, 0.74]

Comparison 1. Diclofenac vs no treatment/placebo

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Comparison 2. Diclofenac vs paracetamol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients requiring rescue analgesia Show forest plot	2	107	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.40, 1.01]

Comparison 2. Diclofenac vs paracetamol

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Comparison 3. Diclofenac vs any other treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Nausea and/or vomiting Show forest plot	13	775	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.47, 0.73]

2 Bleeding requiring surgical intervention Show forest plot	7	463	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.31, 4.97]

Comparison 3. Diclofenac vs any other treatment

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Comparison 4. Diclofenac vs other NSAIDs

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Nausea and/or vomiting Show forest plot	4	289	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.80, 1.92]

2 Bleeding requiring surgical intervention Show forest plot	1	121	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [0.28, 9.41]

Comparison 4. Diclofenac vs other NSAIDs

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