Table 4

Adverse effects in dental 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)

*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

Edwards et al. BMC Anesthesiology 2004 4:3   doi:10.1186/1471-2253-4-3