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Table 4 Adverse effects in dental pain

From: Individual patient meta-analysis of single-dose rofecoxib in postoperative pain

  

Adverse effects with active

Adverse effects with placebo

  

Number of trials

Drug and dose

Number

Percent

Number

Percent

Relative risk (95% CI)

NNH/NNTp (95% CI)

Any adverse event

13

Rofecoxib 50 mg

459/1330

35

231/570

41

0.9 (0.8 to 1.0)

nc

6

Ibuprofen 400 mg

102/303

34

122/298

41

0.8 (0.7 to 1.0)

nc

1

Diclofenac 50 mg*

72/121

60

31/63

41

1.2 (0.9 to 1.6)

nc

6

Ibuprofen 400 mg

102/303

34

122/298

41

0.8 (0.7 to 1.0)

nc

2

Naproxen 550 mg

27/88

31

25/87

29

1.1 (0.7 to 1.7)

nc

2

Oxycodone 5 mg + paracetamol 325 mg

116/180

64

29/61

48

1.4 (1.02 to 1.8)

5.9 (3.2 to 39)

2

paracetamol 600 mg + codeine 60 mg

146/360

41

24/61

39

1.0 (0.7 to 1.4)

nc

Post-extraction alveolitis

13

Rofecoxib 50 mg

179/1330

13

52/570

9

1.5 (1.1 to 2.1)

24 (14 to 80)

6

Ibuprofen 400 mg

23/304

8

31/298

10

0.7 (0.4 to 1.2)

nc

1

Diclofenac 50 mg*

9/180

5

3/63

5

1.0 (0.3 to 3.8)

nc

6

Ibuprofen 400 mg

23/304

8

31/298

10

0.7 (0.4 to 1.2)

nc

2

Naproxen 550 mg

13/88

15

8/87

10

1.6 (0.7 to 3.4)

nc

2

Oxycodone 5 mg + paracetamol 325 mg

20/180

11

7/61

11

0.9 (0.4 to 2.2)

nc

2

Paracetamol 600 mg + codeine 60 mg

27/360

8

3/61

6

1.3 (0.5 to 3.9)

nc

Dizziness

13

Rofecoxib 50 mg

30/1330

2

25/570

5

0.5 (0.3 to 0.9)

43 (24 to 253)

6

Ibuprofen 400 mg

7/304

3

13/298

5

0.6 (0.3 to 1.4)

nc

1

Diclofenac 50 mg*

9/180

8

5/63

8

0.6 (0.2 to 1.8)

nc

6

Ibuprofen 400 mg

7/304

3

13/298

5

0.6 (0.3 to 1.4)

nc

2

Naproxen 550 mg

1/88

2

1/87

1

0.9 (0.2 to 9.3)

nc

2

Oxycodone 5 mg + paracetamol 325 mg

44/180

24

6/61

10

2.5 (1.1 to 5.6)

6.9 (4.1 to 21)

2

Paracetamol 600 mg + codeine 60 mg

19/360

1

1/61

2

3.3 (0.5 to 24)

nc

Drowsiness

13

Rofecoxib 50 mg

8/1330

0.6

1/570

0.6

0.9 (0.3 to 3.1)

nc

6

Ibuprofen 400 mg

1/304

0.7

0/298

0.5

1.3 (0.2 to 11)

nc

1

Diclofenac 50 mg*

5/180

3

0/63

0

3.5 (0.2 to 64)

nc

6

Ibuprofen 400 mg

1/304

0.7

0/298

0.5

1.3 (0.2 to 11)

nc

2

Naproxen 550 mg

0/88

0

0/87

0

0.9 (0.0 to 16)

nc

2

Oxycodone 5 mg + paracetamol 325 mg

6/180

4

1/61

2

2.2 (0.3 to 18)

nc

2

Paracetamol 600 mg + codeine 60 mg

7/360

2

1/61

2

1.2 (0.2 to 9.2)

nc

Nausea

13

Rofecoxib 50 mg

112/1330

8

80/570

14

0.6 (0.5 to 0.8)

18 (11 to 41)

6

Ibuprofen 400 mg

38/304

12

51/298

17

0.7 (0.5 to 1.08)

nc

1

Diclofenac 50 mg*

21/180

12

10/63

16

0.7 (0.4 to 1.5)

nc

6

Ibuprofen 400 mg

38/304

12

51/298

17

0.7 (0.5 to 1.08)

nc

2

Naproxen 550 mg

4/88

5

3/87

3

1.3 (0.3 to 5.7)

nc

2

Oxycodone 5 mg + paracetamol 325 mg

61/180

34

10/61

17

2.0 (1.1 to 3.5)

6.0 (3.5 to 19)

2

Paracetamol 600 mg + codeine 60 mg

70/360

19

6/61

10

2.0 (0.9 to 4.4)

10 (5.5 to 92)

Vomiting

13

Rofecoxib 50 mg

51/1330

4

51/570

9

0.4 (0.3 to 0.6)

19 (13 to 38)

6

Ibuprofen 400 mg

25/304

8

36/298

12

0.7 (0.4 to 1.1)

nc

1

Diclofenac 50 mg*

6/180

3

7/63

11

0.3 (0.1 to 1.0)

nc

2

Naproxen 550 mg

1/88

2

1/87

2

0.9 (0.1 to 9.3)

nc

2

Oxycodone 5 mg + paracetamol 325 mg

35/180

19

3/61

6

3.4 (1.2 to 9.8)

7.2 (4.6 to 18)

2

Paracetamol 600 mg + codeine 60 mg

58/360

16

4/61

7

2.46 (0.9 to 6.5)

10 (5.9 to 44)

  1. *NB: Diclofenac was taken every eight hours during the study. Naproxen was given as the sodium salt Bold type: NNTp to prevent one event (significantly fewer events occurred with rofecoxib 50 mg compared with placebo
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