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Comparison 1 50% pain relief using pain relief measures, Outcome 1 Paracetamol versus placebo: number of people with at least 50% pain relief at 4 hours.
Figuras y tablas -
Analysis 1.1

Comparison 1 50% pain relief using pain relief measures, Outcome 1 Paracetamol versus placebo: number of people with at least 50% pain relief at 4 hours.

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Comparison 1 50% pain relief using pain relief measures, Outcome 2 Paracetamol versus placebo: number of people with at least 50% pain relief at 6 hours.
Figuras y tablas -
Analysis 1.2

Comparison 1 50% pain relief using pain relief measures, Outcome 2 Paracetamol versus placebo: number of people with at least 50% pain relief at 6 hours.

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Comparison 2 50% pain relief using pain intensity measures, Outcome 1 Paracetamol versus placebo: number of people with at least 50% pain relief at 4 hours.
Figuras y tablas -
Analysis 2.1

Comparison 2 50% pain relief using pain intensity measures, Outcome 1 Paracetamol versus placebo: number of people with at least 50% pain relief at 4 hours.

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Comparison 2 50% pain relief using pain intensity measures, Outcome 2 Paracetamol versus placebo: number of people with at least 50% pain relief at 6 hours.
Figuras y tablas -
Analysis 2.2

Comparison 2 50% pain relief using pain intensity measures, Outcome 2 Paracetamol versus placebo: number of people with at least 50% pain relief at 6 hours.

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Comparison 3 Number of people with adverse events, Outcome 1 Number of patients with adverse events: paracetamol versus placebo.
Figuras y tablas -
Analysis 3.1

Comparison 3 Number of people with adverse events, Outcome 1 Number of patients with adverse events: paracetamol versus placebo.

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Table 1. Random‐effects metaregression: < 1000 mg vs 1000 mg, Paracetamol vs Placebo

Outcome

Number of studies

Slope estimate

95% CI

Slope interpretation

P value

50% pain relief at 4 hours (using pain relief)

16

0.94

(0.36 to 1.52)

more pain relief for higher doses

0.001

50% pain relife at 6 hours (using pain relief)

13

1.14

(0.71 to 1.56)

more pain relief for higher doses

<0.001

50% pain relief at 4 hours (using pain intensity)

16

0.23

(‐0.84 to 1.30)

more pain relief for higher doses

0.67

50% pain relief at 6 hours (using pain intensity)

14

0.43

(‐0.15 to 1.01)

more pain relief for higher doses

0.15
Figuras y tablas -
Table 1. Random‐effects metaregression: < 1000 mg vs 1000 mg, Paracetamol vs Placebo
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Table 2. Number of patients with adverse events (< 1000 mg Paracetamol/Placebo)

Author

Total: Paracetamol

AEs: Paracetamol

Total: Placebo

AEs: Placebo

Cooper 1980

37

2

37

6

Cooper 1981

37

12

38

4

Dionne 1994

27

7

25

5

Dolci 1994

80

7

82

8

Forbes 1984b

43

1

40

2

Forbes 1989

26

3

26

2

Forbes 1990

41

5

38

0

Gallardo 1990

15

5

11

3

Seymour 1996

40

0

39

0

Sunshine 1986

30

1

30

1

Vattaraphudej 1986

16

0

19

0

Totals

392

43

385

31
Figuras y tablas -
Table 2. Number of patients with adverse events (< 1000 mg Paracetamol/Placebo)
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Table 3. Number of patients with adverse effects (< 1000 mg Paracetamol/No placebo)

Author

Total: Paracetamol

Total: Adverse events

Nystrom 1990

45

5

Quiding 1981

27

3

Ragot 1991

40

1

Reijntes 1987

29

2

Selcuk 1996

52

0

Strom 1990

33

6

Totals

226

17
Figuras y tablas -
Table 3. Number of patients with adverse effects (< 1000 mg Paracetamol/No placebo)
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Table 4. Number of patients with adverse events (1000 mg Paracetamol/Placebo)

Author

Total: Paracetamol

AEs: Paracetamol

Total: Placebo

AEs: Placebo

Cooper 1998

50

25

26

4

Hersch 2000

63

12

27

7

Kiersch 1994

91

26

47

13

Kubitzek 2003

78

4

84

2

Lehnert 1990

49

5

40

4

Mehlisch 1990

307

32

85

12

Mehlisch 1995

99

12

40

4

Moller 2000

120

48

122

56

Olson 2001

66

10

39

2

Seymour 1996

40

0

39

0

Seymour 2003

62

24

32

9

Totals

1025

198

581

113
Figuras y tablas -
Table 4. Number of patients with adverse events (1000 mg Paracetamol/Placebo)
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Table 5. Number of patients with adverse events (1000 mg Paracetamol/No placebo)

Author

Total: Paracetamol

AEs: Paracetamol

Dionne 1983 (1)

20

12

Nystrom 1990

46

7

Ragot 1991

40

0

Strom 1990

176

19

Totals

282

38
Figuras y tablas -
Table 5. Number of patients with adverse events (1000 mg Paracetamol/No placebo)
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Table 6. Number of patients with adverse events (All doses of Paracetamol/Placebo)

Author

Total: Paracetamol

AEs: Paracetamol

Total: Placebo

AEs: Placebo

Cooper 1980

37

2

37

6

Cooper 1981

37

12

38

4

Cooper 1998

50

25

26

4

Dionne 1994

27

7

25

5

Dolci 1994

80

7

82

8

Forbes 1984b

43

1

40

2

Forbes 1989

26

3

26

2

Forbes 1990

41

5

38

0

Gallardo 1990

15

5

11

3

Hersch 2000

63

12

27

7

Kiersch 1994

91

26

47

13

Kubitzek 2003

78

4

84

2

Lehnert 1990

49

5

40

4

Mehlisch 1990

307

32

85

12

Mehlisch 1995

99

12

40

4

Moller 2000

120

48

122

56

Olson 2001

66

10

39

2

Seymour 1996

80

0

39

0

Seymour 2003

62

24

32

9

Sunshine 1986

30

1

30

1

Vattaraphudej 1986

16

0

19

0

Totals

1417

241

927

144
Figuras y tablas -
Table 6. Number of patients with adverse events (All doses of Paracetamol/Placebo)
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Table 7. Number of patients with adverse events (All doses of Paracetamol/No placebo)

Author

Totals: Paracetamol

AEs: Paracetamol

Dionne 1983 (1)

20

12

Nystrom 1990

91

12

Quiding 1981

27

3

Ragot 1991

80

1

Reintjes 1987

29

2

Selcuk 1996

52

0

Strom 1990

209

25

Totals

508

55
Figuras y tablas -
Table 7. Number of patients with adverse events (All doses of Paracetamol/No placebo)
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Table 8. Total number of adverse events (< 1000 mg Paracetamol/Placebo)

Author

Total: Paracetamol

AEs: Paracetamol

Total: Placebo

AEs: Placebo

Cooper 1980

37

6

38

7

Cooper 1981

37

15

37

5

Dionne 1994

27

9

25

5

Dolci 1994

80

7

82

12

Forbes 1984b

43

2

40

2

Forbes 1990

41

5

38

0

Gallardo 1990

15

5

11

3

Sunshine 1986

30

1

30

2

Totals

310

50

301

36
Figuras y tablas -
Table 8. Total number of adverse events (< 1000 mg Paracetamol/Placebo)
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Table 9. Total number of adverse events (< 1000 mg Paracetamol/No placebo)

Author

Total: Paracetamol

AEs: Paracetamol

Haanaes 1986

36

11

Nystrom 1988

45

6

Quiding 1981

27

4

Ragot 1991

40

1

Reintjes 1987

29

2

Selcuk 1996

52

0

Totals

229

24
Figuras y tablas -
Table 9. Total number of adverse events (< 1000 mg Paracetamol/No placebo)
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Table 10. Total number of adverse events (1000 mg Paracetamol/Placebo)

Author

Totals: Paracetamol

AEs: Paracetamol

Totals: Placebo

AEs: Placebo

Breivik 1998

119

17

54

10

Cooper 1998

50

26

26

5

Hersh 2000

63

14

27

8

Kiersch 1994

91

35

47

18

Moller 2000

120

65

122

83

Olson 2001

66

10

39

2

Seymour 2003

62

36

28

13

Skoglund 1991

67

12

33

10

Totals

638

215

376

149
Figuras y tablas -
Table 10. Total number of adverse events (1000 mg Paracetamol/Placebo)
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Table 11. Total number of adverse events (1000 mg Paracetamol/No placebo)

Author

Totals: Paracetamol

AEs: Paracetamol

Dionne 1983

20

18

Nystrom 1990

46

10

Ragot 1991

40

0

Totals

106

28
Figuras y tablas -
Table 11. Total number of adverse events (1000 mg Paracetamol/No placebo)
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Table 12. Total number of adverse events (All doses of Paracetamol/Placebo)

Author

Totals: Paracetamol

AEs: Paracetamol

Totals: Placebo

AEs: Placebo

Breivik 1998

119

17

54

10

Cooper 1980

37

6

38

7

Cooper 1981

37

15

37

5

Cooper 1998

50

26

26

5

Dionne 1994

27

9

25

5

Dolci 1994

80

7

82

12

Forbes 1984b

43

2

40

2

Forbes 1990

41

5

38

0

Gallardo 1990

15

5

11

3

Hersh

63

14

27

8

Kiersch 1994

91

35

47

18

Moller 2000

120

65

122

83

Olson 2001

66

10

39

2

Seymour 2003

62

36

28

13

Skoglund 1991

67

12

33

10

Sunshine 1986

30

1

30

2

Totals

948

265

647

185
Figuras y tablas -
Table 12. Total number of adverse events (All doses of Paracetamol/Placebo)
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Table 13. Total number of adverse events (All doses of Paracetamol/No placebo)

Author

Totals: Paracetamol

AEs: Paracetamol

Dionne 1983

20

18

Haanaes 1986

36

11

Nystrom 1988

91

16

Quiding 1981

27

4

Ragot 1991

80

1

Reijntes 1987

29

2

Selcuk 1996

52

0

Totals

335

52
Figuras y tablas -
Table 13. Total number of adverse events (All doses of Paracetamol/No placebo)
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Table 14. Global assessment ‐ 5‐point scale(< 1000 mg Paracetamol)

Author

Total: Paracetamol

Global assessment

Total: Placebo

Global assessment

Cooper 1980

37

0.89

38

0.89

Cooper 1981

37

1.92

37

0.62

Cooper 1988

36

2.38

40

2.05

Dionne 1994

27

2.40

25

2.00

Dolci 1994

72

2.10

76

2.17

Forbes 1984

39

1.26

36

0.28

Mean

248

1.83

252

1.44
Figuras y tablas -
Table 14. Global assessment ‐ 5‐point scale(< 1000 mg Paracetamol)
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Table 15. Global assessment ‐ 4‐point scale (< 1000 mg Paracetamol)

Author

Total: Paracetamol

Global assessment

Total: Placebo

Global assessment

Forbes 1989

26

1.00

26

0.30

Forbes 1990

41

1.47

38

0.56

Sunshine 1986

30

1.20

30

0.93

Vattaraphudej 1986

16

1.6

19

1.16

Mean

113

1.31

113

0.70
Figuras y tablas -
Table 15. Global assessment ‐ 4‐point scale (< 1000 mg Paracetamol)
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Table 16. Global assessment ‐ 5‐point scale (1000 mg Paracetamol)

Author

Total: Paracetamol

Global assessment

Total: Placebo

Global assessment

Kiersch 1994

91

1.30

47

0.60

Kubitzek 2003

78

1.98

84

1.45

Mehlisch 1995

101

1.57

40

0.45

Olson 2001

66

2.81

39

1.93

Seymour 2003

62

2.50

32

2.14

Mean

398

1.94

242

1.29
Figuras y tablas -
Table 16. Global assessment ‐ 5‐point scale (1000 mg Paracetamol)
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Table 17. Global assessment ‐ 4‐point scale (1000 mg Paracetamol)

Author

Total: Paracetamol

Global assessment

Total: Placebo

Global assessment

Hersh 2000

63

2.29

27

0.85

Moller 2000

120

1.88

122

1.54

Mean

183

2.02

149

1.41
Figuras y tablas -
Table 17. Global assessment ‐ 4‐point scale (1000 mg Paracetamol)
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Table 18. Quality assessment

Author

Allocation concealment

Follow up

Total (Max‐3)

Cooper 1980

1

0

1

Cooper 1981

1

0

1

Cooper 1988

1

0

1

Cooper 1998

1

1

2

Dionne 1994

1

0

1

Dolci 1994

1

0

1

Forbes 1984b

2

0

2

Forbes 1989

1

0

1

Forbes 1990

2

0

2

Hersh 2000

1

1

2

Kiersch 1994

1

1

2

Kubitzek 2003

1

1

2

Lehnert 1990

1

1

2

Mehlisch 1995

2

1

3

Moller 2000

1

1

2

Olson 2001

2

1

3

Seymour 1996

1

1

2

Seymour 2003

2

0

2

Skoglund 1991

2

0

2

Sunshine 1986

2

1

3

Vattaraphudej 1986

1

1

2
Figuras y tablas -
Table 18. Quality assessment
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Table 19. Sample size calculation

Author

Yes/No

Cooper 1980

No

Cooper 1981

No

Cooper 1988

No

Cooper 1998

No

Dionne 1994

No

Dolci 1994

No

Forbes 1984

No

Forbes 1989

No

Forbes 1990

No

Hersh 2000

No

Kiersch 1994

No

Kubitzek 2003

Yes

Lehnert 1990

No

Mehlisch 1995

No

Moller 2000

Yes

Olson 2001

No

Seymour 1996

No

Seymour 2003

Yes

Skoglund 1991

No

Sunshine 1986

No

Vattaraphudej 1986

No
Figuras y tablas -
Table 19. Sample size calculation
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Table 20. Agreement between quality assessors

Author

Yes/No

Cooper 1980

Yes

Cooper 1981

Yes

Cooper 1988

Yes

Cooper 1998

Yes

Dionne 1994

Yes

Dolci 1994

Yes

Forbes 1984

Yes

Forbes 1989

Yes

Forbes 1990

Yes

Hersh 2000

Yes

Kiersch 1994

Yes

Kubitzek 2003

Yes

Lehnert 1990

Yes

Mehlisch 1995

Yes

Moller 2000

Yes

Olson 2001

Yes

Seymour 1996

Yes

Seymour 2003

Yes

Skoglund 1991

No

Sunshine 1986

Yes

Vattaraphudej 1986

No
Figuras y tablas -
Table 20. Agreement between quality assessors
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Table 21. List of adverse events

Adverse events

Paracetamol

Placebo

Nausea

21

11

Vomiting

11

3

Nausea and/or vomiting, stomach cramps, abdominal pain

3

3

Headache

47

31

Drowsiness, sleepiness, somnolence

36

13

Dizziness, fainting, syncope

9

4

Bleeding

11

7

Chills, flushes, fever, flu‐like symptoms

5

0

Paraesthesia

4

2

Jawache

1

0

Swelling

1

6

Cellulitis

1

0

Dry socket

11

12

Surgical complications

6

13

CNS

5

6

GI

12

2

Body as a whole

8

3

Respiratory

2

0

Psychiatric

0

1

Other, hiccups, hearing/vestibular, miosis,

5

1
Figuras y tablas -
Table 21. List of adverse events
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Comparison 1. 50% pain relief using pain relief measures

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Paracetamol versus placebo: number of people with at least 50% pain relief at 4 hours Show forest plot

16

1498

Risk Ratio (M‐H, Random, 95% CI)

2.85 [1.89, 4.29]

1.1 Up to 1000 mg of paracetamol

10

710

Risk Ratio (M‐H, Random, 95% CI)

1.96 [1.34, 2.86]

1.2 1000 mg or more

6

788

Risk Ratio (M‐H, Random, 95% CI)

4.56 [2.86, 7.27]

2 Paracetamol versus placebo: number of people with at least 50% pain relief at 6 hours Show forest plot

13

1155

Risk Ratio (M‐H, Random, 95% CI)

3.32 [1.88, 5.87]

2.1 Up to 1000 mg of paracetamol

6

378

Risk Ratio (M‐H, Random, 95% CI)

1.89 [0.98, 3.67]

2.2 1000 mg or more

7

777

Risk Ratio (M‐H, Random, 95% CI)

4.21 [2.97, 5.98]
Figuras y tablas -
Comparison 1. 50% pain relief using pain relief measures
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Comparison 2. 50% pain relief using pain intensity measures

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Paracetamol versus placebo: number of people with at least 50% pain relief at 4 hours Show forest plot

17

1658

Risk Ratio (M‐H, Random, 95% CI)

4.87 [2.83, 8.37]

1.1 Up to 1000 mg of paracetamol

10

737

Risk Ratio (M‐H, Random, 95% CI)

4.33 [2.19, 8.58]

1.2 1000 mg or more

8

921

Risk Ratio (M‐H, Random, 95% CI)

6.46 [2.34, 17.85]

2 Paracetamol versus placebo: number of people with at least 50% pain relief at 6 hours Show forest plot

13

1184

Risk Ratio (M‐H, Random, 95% CI)

3.41 [2.34, 4.97]

2.1 Up to 1000 mg of paracetamol

6

403

Risk Ratio (M‐H, Random, 95% CI)

2.67 [1.46, 4.90]

2.2 1000 mg or more

8

781

Risk Ratio (M‐H, Random, 95% CI)

3.96 [2.52, 6.23]
Figuras y tablas -
Comparison 2. 50% pain relief using pain intensity measures
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Comparison 3. Number of people with adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of patients with adverse events: paracetamol versus placebo Show forest plot

17

1645

Risk Ratio (M‐H, Random, 95% CI)

1.19 [0.90, 1.57]

1.1 Up to 1000 mg of paracetamol

9

672

Risk Ratio (M‐H, Random, 95% CI)

1.25 [0.69, 2.25]

1.2 1000 mg or more

8

973

Risk Ratio (M‐H, Random, 95% CI)

1.16 [0.84, 1.60]
Figuras y tablas -
Comparison 3. Number of people with adverse events
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