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Forest plot of comparison: 3 Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo, outcome: 1.1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Figure 1

Forest plot of comparison: 3 Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo, outcome: 1.1 Participants with at least 50% pain relief over 4 to 6 hours.

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Forest plot of comparison: 5 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, outcome: 3.1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Figure 2

Forest plot of comparison: 5 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, outcome: 3.1 Participants with at least 50% pain relief over 4 to 6 hours.

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Forest plot of comparison: 7 Paracetamol 300 mg plus codeine 30 mg versus placebo, outcome: 5.1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Figure 3

Forest plot of comparison: 7 Paracetamol 300 mg plus codeine 30 mg versus placebo, outcome: 5.1 Participants with at least 50% pain relief over 4 to 6 hours.

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Forest plot of comparison: 4 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, outcome: 2.1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Figure 4

Forest plot of comparison: 4 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, outcome: 2.1 Participants with at least 50% pain relief over 4 to 6 hours.

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Forest plot of comparison: 6 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600 to 650 mg, outcome: 4.1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Figure 5

Forest plot of comparison: 6 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600 to 650 mg, outcome: 4.1 Participants with at least 50% pain relief over 4 to 6 hours.

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Forest plot of comparison: 5 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, outcome: 3.4 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Figure 6

Forest plot of comparison: 5 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, outcome: 3.4 Participants using rescue medication over 4 to 6 hours.

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Forest plot of comparison: 7 Paracetamol 300 mg plus codeine 30 mg versus placebo, outcome: 5.4 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Figure 7

Forest plot of comparison: 7 Paracetamol 300 mg plus codeine 30 mg versus placebo, outcome: 5.4 Participants using rescue medication over 4 to 6 hours.

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Forest plot of comparison: 6 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600 to 650 mg, outcome: 4.4 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Figure 8

Forest plot of comparison: 6 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600 to 650 mg, outcome: 4.4 Participants using rescue medication over 4 to 6 hours.

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Forest plot of comparison: 8 Paracetamol plus codeine (all doses) versus placebo, outcome: 8.1 Participants with at least one adverse event.
Figuras y tablas -
Figure 9

Forest plot of comparison: 8 Paracetamol plus codeine (all doses) versus placebo, outcome: 8.1 Participants with at least one adverse event.

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Forest plot of comparison: 5 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, outcome: 3.5 Participants with any adverse event.
Figuras y tablas -
Figure 10

Forest plot of comparison: 5 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, outcome: 3.5 Participants with any adverse event.

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Forest plot of comparison: 9 Paracetamol plus codeine (all doses) versus paracetamol alone, outcome: 9.1 Participants with any adverse event.
Figuras y tablas -
Figure 11

Forest plot of comparison: 9 Paracetamol plus codeine (all doses) versus paracetamol alone, outcome: 9.1 Participants with any adverse event.

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Comparison 1 Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 1.1

Comparison 1 Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 1 Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo, Outcome 2 Participants with any adverse event.
Figuras y tablas -
Analysis 1.2

Comparison 1 Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo, Outcome 2 Participants with any adverse event.

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Comparison 2 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 2.1

Comparison 2 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 2 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, Outcome 2 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Analysis 2.2

Comparison 2 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, Outcome 2 Participants using rescue medication over 4 to 6 hours.

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Comparison 2 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, Outcome 3 Participants with any adverse event.
Figuras y tablas -
Analysis 2.3

Comparison 2 Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg, Outcome 3 Participants with any adverse event.

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Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 3.1

Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 2 Participants with at least 50% pain relief over 4 to 6 hours, dental.
Figuras y tablas -
Analysis 3.2

Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 2 Participants with at least 50% pain relief over 4 to 6 hours, dental.

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Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery.
Figuras y tablas -
Analysis 3.3

Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery.

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Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 4 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Analysis 3.4

Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 4 Participants using rescue medication over 4 to 6 hours.

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Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 5 Participants with any adverse event.
Figuras y tablas -
Analysis 3.5

Comparison 3 Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo, Outcome 5 Participants with any adverse event.

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Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 4.1

Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 2 Participants with at least 50% pain relief over 4 to 6 hours, dental.
Figuras y tablas -
Analysis 4.2

Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 2 Participants with at least 50% pain relief over 4 to 6 hours, dental.

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Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery.
Figuras y tablas -
Analysis 4.3

Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery.

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Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 4 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Analysis 4.4

Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 4 Participants using rescue medication over 4 to 6 hours.

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Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 5 Participants with any adverse event.
Figuras y tablas -
Analysis 4.5

Comparison 4 Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg, Outcome 5 Participants with any adverse event.

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Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 5.1

Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 2 Participants with at least 50% pain relief over 4 to 6 hours, dental.
Figuras y tablas -
Analysis 5.2

Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 2 Participants with at least 50% pain relief over 4 to 6 hours, dental.

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Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery.
Figuras y tablas -
Analysis 5.3

Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery.

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Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 4 Participants using rescue medication over 4 to 6 hours.
Figuras y tablas -
Analysis 5.4

Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 4 Participants using rescue medication over 4 to 6 hours.

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Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 5 Participants with any adverse event.
Figuras y tablas -
Analysis 5.5

Comparison 5 Paracetamol 300 mg plus codeine 30 mg versus placebo, Outcome 5 Participants with any adverse event.

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Comparison 6 Sensitivity analysis (paracetamol with codeine versus placebo), Outcome 1 Fewer than 40 patients in active and placebo groups, participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 6.1

Comparison 6 Sensitivity analysis (paracetamol with codeine versus placebo), Outcome 1 Fewer than 40 patients in active and placebo groups, participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 6 Sensitivity analysis (paracetamol with codeine versus placebo), Outcome 2 More than 40 patients in active and placebo groups, participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 6.2

Comparison 6 Sensitivity analysis (paracetamol with codeine versus placebo), Outcome 2 More than 40 patients in active and placebo groups, participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 7 Sensitivity analysis (paracetamol with codeine versus paracetamol), Outcome 1 Fewer than 40 patients in active and control groups, Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 7.1

Comparison 7 Sensitivity analysis (paracetamol with codeine versus paracetamol), Outcome 1 Fewer than 40 patients in active and control groups, Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 7 Sensitivity analysis (paracetamol with codeine versus paracetamol), Outcome 2 More than 40 patients in active and control groups, Participants with at least 50% pain relief over 4 to 6 hours.
Figuras y tablas -
Analysis 7.2

Comparison 7 Sensitivity analysis (paracetamol with codeine versus paracetamol), Outcome 2 More than 40 patients in active and control groups, Participants with at least 50% pain relief over 4 to 6 hours.

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Comparison 8 Paracetamol plus codeine (all doses) versus placebo, Outcome 1 Participants with any adverse event.
Figuras y tablas -
Analysis 8.1

Comparison 8 Paracetamol plus codeine (all doses) versus placebo, Outcome 1 Participants with any adverse event.

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Comparison 9 Paracetamol plus codeine (all doses) versus paracetamol alone, Outcome 1 Participants with any adverse event.
Figuras y tablas -
Analysis 9.1

Comparison 9 Paracetamol plus codeine (all doses) versus paracetamol alone, Outcome 1 Participants with any adverse event.

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Table 1. Summary of outcomes ‐ analgesia and use of rescue medication

Analgesia

Rescue medication

Study ID

Treatment

PI or PR

Number with 50% PR

PGE: v good or excellent

Median time to use (hr)

Number using

Bentley 1987

(1) Paracetamol+codeine 1000/60 mg, n=41

(2) Paracetamol 1000 mg, n=41

(3) Codeine 60 mg, n=21

(4) Placebo, n=17

TOTPAR 5:

(1) 11.5

(2) 8.7

(4) 4.9

(1) 27/41

(2) 19/41

(4) 4/17

No data

(1) 4.1

(2) 3.3

(4) 1.4

at 4 hr:

(1) 44

(2) 68

(4) 81

Bjune 1996

(1) Paracetamol+codeine 800/60 mg, n=50

(2) Paracetamol 1000 mg, n=50

(3) Placebo, n=25

TOTPAR 6:

severe pain

(1) 10.5

(2) 6.4

(3) 0

moderate pain

(1) 6.5

(2) 8.0

(3) 1.5

(1) 16/44

(2) 12/43

(3) 0/21

No usable data

No data

No data

Bourne 2005

(1) Paracetamol+codeine 300/30 mg, n=55

(2) Paracetamol+tramadol 325/37.5 mg, n=49

(3) Placebo, n=49

SPID 4:

(1) 2.8

(3) 2.1

Baseline PI:

(1) 2.1

(2) 2.2

(1) 24/55

(3) 15/49

No usable data

No data

at 4 hr:

(1) 18

(3) 37

Breivik 1999

(1) Paracetamol+codeine 1000/60 mg n=24

(2) Paracetamol 1000 mg, n=22

(3) Diclofenac 100 mg, n=22

(4) Paracetamol+diclofenac 1000/100 mg, n=24

(5) Paracetamol+diclofenac+codeine 1000/100/60 mg, n=24

TOTPAR 6:

(1) 15.5

(2) 12.1

(1) 17/23

(2) 12/22

No data

No data

at 6 hr:

(1) 17

(2) 38

Chang 2001

(1) Paracetamol+codeine 600/60 mg n=180

(2) Rofecoxib 50mg n=182

(3) Placebo n=31

TOTPAR 6:

(1) 7.0

(3) 3.4

(1) 49/180

(3) 2/31

(1) 27/180

(3) 0/31

(1) 2.3

(3) 1.6

No data

Chang 2005

(1) Paracetamol+codeine 600/60 mg n=180

(2) Rofecoxib 50 mg n=180

(3) Placebo n=30

TOTPAR 6:

(1) 10.7

(3) 6.7

(1) 86/180

(3) 8/30

(1) 123/180

(3) 3/30

(1) 6.5

(3) 3.2

at 24 hr:

(1) 86

(3) 73

Cooper 1981

(1) Paracetamol+codeine 650/60 mg, n=42

(2) Paracetamol 650 mg, n=37

(3) Paracetamol+d‐propoxyphene 650/100 mg, n=42

(4) Ibuprofen 200 mg, n=42

(5) Placebo, n=37

TOTPAR 4:

(1) 8.4

(2) 8.2

(5) 3.4

(1) 24/42

(2) 21/37

(5) 6/37

No usable data

Mean:

(1) 3.1

(2) 3.5

(5) 2.9

at 4 hr:

(1) 12

(2) 5

(5) 54

Cooper 1988

(1) Paracetamol+codeine 600/60 mg, n=31

(2) Paracetamol 600 mg, n=36

(3) Meclofenamate Na 100 mg, n=36

(2) Placebo, n=40

TOTPAR 6:

(1) 12.0

(2) 8.0

(4) 6.3

(1) 17/31

(2) 12/36

(4) 9/40

(1) 15/31

(2) 12/36

(4) 8/40

No data

at 6 hr:

(1) 58

(2) 78

(4) 82

Cooper 1991

(1) Paracetamol+codeine 650/60 mg, n=39

(2) Paracetamol 650 mg, n=37

(3) Zomepirac 100 mg, n=23

(4) Flurbiprofen 50 mg, n=42

(5) Flurbiprofen 100 mg, n=41

(6) Placebo, n=44

TOTPAR 6:

(1) 10.1

(2) 6.8

(6) 5.7

(1) 17/39

(2) 10/37

(6) 9/44

(1) 14/39

(2) 3/37

(6) 2/44

Mean:

(1) 3.5

(2) 3.2

(6) 3.1

at 6 hr:

(1) 80

(2) 95

(6) 84

Desjardins 1986

(1) Paracetamol+codeine 300/30 mg, n=39

(2) Aspirin+butalbital+caffeine+codeine 325/50/40/30 mg, n=43

(3) Placebo, n=41

TOTPAR 6:

(1) 7.8

(3) 5.1

(1) 12/39

(3) 7/41

No usable data

Mean:

(1) 3.4

(3) 3.0

No data

Dionne 1994

(1) Paracetamol+codeine 650/60 mg, n=24

(2) Paracetamol 650 mg, n=27

(3) Flurbiprofen 50 mg, n=25

(4) Flurbiprofen 100 mg, n=22

(5) Placebo, n=25

TOTPAR 6:

(1) 16.9

(2) 18.4

(5) 14.9

(1) 20/24

(2) 24/27

(5) 18/25

No usable data

No data

No data

Forbes 1982

(1) Paracetamol+codeine 600/60 mg, n=31

(2) Paracetamol 600 mg, n=34

(3) Diflusinal 500 mg, n=32

(4) Diflusinal 1000 mg, n=32

(5) Placebo, n=30

TOTPAR 4:

(1) 9.7

(2) 8.9

(5) 3.8

(1) 21/31

(2) 15/34

(5) 6/30

No usable data

(1) 5.3

(2) 3.5

(5) 2.4

at 6 hr:

(1) 56

(2) 70

(5) 82

Forbes 1983

(1) Paracetamol+codeine 600/60 mg, n=26

(2) Paracetamol 600 mg, n=26

(3) Diflusinal 500 mg, n=26

(4) Diflusinal 1000 mg, n=28

(5) Placebo, n=26

TOTPAR 6:

(1) 13.5

(2) 11.2

(5) 5.4

(1) 16/26

(2) 13/26

(5) 5/26

No usable data

(1) 5.3

(2) 4.0

(5) 2.4

at 6 hr:

(1) 63

(2) 73

(5) 86

Forbes 1986

(1) Paracetamol+codeine 300/30 mg, n=43

(2) Aspirin+butalbital+caffeine+codeine 325/50/40/15 mg, n=41

(3) Placebo, n=38

TOTPAR 6:

(1) 7.4

(3) 2.4

(1) 13/43

(2) 1/38

No usable data

Mean:

(1) 4.5

(2) 3.0

No data

Forbes 1989

(1) Paracetamol+codeine 600/60 mg, n=17

(2) Paracetamol 600 mg, n=22

(3) Flurbiprofen 100 mg, n=26

(4) Placebo, n=23

TOTPAR 6:

(1) 10.5

(2) 4.5

(3) 2.0

(1) 8/17

(2) 1/22

(4) 0/23

No usable data

(1) 5.1

(2) 2.8

(4) 1.7

at 6 hr:

(1) 64

(2) 82

(4) 91

Forbes 1990a

(1) Paracetamol+codeine 600/60 mg, n=27

(2) Aspirin 650 mg, n=32

(3) Ketorolac 10 mg, n=37

(4) Placebo, n=32

TOTPAR 6:

(1) 8.6

(4) 2.9

(1) 9/27

(4) 1/32

No usable data

Mean:

(1) 4.3

(4) 3.1

at 6 hr:

(1) 85

(4) 84

Forbes 1990b

(1) Paracetamol+codeine 600/60 mg, n=38

(2) Paracetamol 600 mg, n=36

(3) Ketorolac 10 mg, n=31

(4) Ketorolac 20 mg, n=35

(5) ibuprofen 400 mg, n=32

(6) Placebo, n=34

TOTPAR 6:

(1) 6.2

(2) 5.8

(6) 1.9

(1) 9/38

(2) 7/36

(6) 0/34

No usable data

(1) 2.6

(2) 3.0

(6) 1.8

at 6 hr:

(1) 82

(2) 81

(6) 97

Forbes 1994

(1) Paracetamol+codeine 300/30 mg, n=93

(2) Paracetamol+hydrocodone bitartrate 500/7.5 mg, n=94

(3) Placebo, n=45

TOTPAR 6:

(1) 6.6

(3) 3.4

(1) 23/93

(3) 3/45

No usable data

Mean:

(1) 3.9

(3) 3.4

at 6 hr:

(1) 77

(3) 87

Gertzbein 1986

(1) Paracetamol+codeine 1000/60 mg, n=45

(2) Paracetamol 1000 mg, n=45

TOTPAR 5:

(1) 11.5

(2) 10.2

(1) 30/45

(2) 25/45

No usable data

Mean:

(1) 3.8

(2) 3.6

No data

Heidrich 1985

(1) Paracetamol+codeine 300/30 mg, n=40

(2) Ibuprofen 400 mg, n=40

(3) Placebo, n=40

TOTPAR 6:

(1) 5.5

(3) 3.3

(1) 8/40

(3) 3/40

No data

Mean:

(1) 4.7

(3) 3.5

(1) 85

(3) 90

Honig 1984

(1) Paracetamol+codeine 600/60 mg, n=30

(2) Paracet 600 mg, n=28

(3) Codeine 60 mg, n=28

(4) Placebo, n=30

TOTPAR 6:

(1) 10.6

(2) 8.9

(4) 5.9

(1) 14/30

(2) 11/28

(4) 6/30

(1) 12/30

(2) 8/28

(4) 4/30

No data

at 6 hr:

(1) 33

(2) 43

(4) 53

Malmstrom 2004

(1) Paracetamol+codeine 600/60 mg, n=50

(2) Etoricoxib 120 mg, n=50

(3) Naproxen sodium 550 mg, n=50

(4) Placebo, n=50

TOTPAR 6:

(1) 9.2

(4) 4.2

(1) 20/50

(4) 6/50

at 8 hr:

(1) 24/50

(4) 7/50

(1) 3.6

(4) 1.6

at 24 hr:

(1) 76

(4) 99

Pande 1996a

(1) Paracetamol+codeine 600/60 mg, n=23

(2) Placebo, n=26

SPID 6:

(1) 3.1

(2) 0

Baseline PI: 2.5

(1) 6/23

(2) 0/26

No usable data

No data

No data

Smith 2004

1)Paracetamol+codeine 300/30 mg, n=109

2) Paracetamol+tramadol 325/37.5 mg, n=98

3) Placebo n=98

SPID 4:

(1) 2.7

(3) 2.0

(1) 43/109

(3) 27/98

No usable data

No data

at 4 hr:

(1) 26

(3) 40

Stubhaug 1995

(1) Paracetamol+codeine 1000/60 mg, n=36

(2) Tramadol 50 mg, n=33

(3) Tramadol 100 mg, n=35

(4) Placebo, n=33

VAS SPID 6:

(1) 204

(4) 17

Baseline PI:

(1) 67

(4) 66

(1) 21/36

(4) 1/33

No usable data

(1) >6

(4) 2.8

at 6 hr:

(1) 36

(4) 82

Sunshine 1986

(1) Paracetamol+codeine 650/60 mg, n=31

(2) Paracetamol 650 mg, n=30

(3) Flurbiprofen 50 mg, n=31

(4) Flurbiprofen 100 mg, n=29

(5) Zomepirac 100 mg, n=31

(6) Placebo, n=30

TOTPAR 6:

(1) 13.4

(2) 11.1

(6) 8.3

(1) 19/31

(2) 15/30

(6) 10/30

No usable data

No data

at 6 hr:

(1) 30

(2) 47

(6) 43

Turek 1988

(1) Paracetamol+codeine 650/60 mg, n=39

(2) Ketoprofen 50 mg, n=41

(3) Ketoprofen 150 mg, n=39

(4) Placebo, n=41

TOTPAR 6:

(1) 8.1

(4) 4.6

(1) 14/39

(4) 8/41

No usable data

Mean:

(1) 3.5

(4) 2.2

at 6 hr:

(1) 67

(4) 83

Ziccardi 2000

(1) Paracetamol+codeine 300/30 mg, n=49

(2) Ibuprofen+hydrocodone 200/75 mg, n=49

(3) Placebo, n=27

TOTPAR 6:

(1) 9.8

(3) 3.5

(1) 21/49

(3) 2/27

No usable data

(1) 3.0

(3) 1.0

No data
Figuras y tablas -
Table 1. Summary of outcomes ‐ analgesia and use of rescue medication
Ir a la tabla de la revisión
Table 2. Summary of outcomes ‐ adverse events and withdrawals

Adverse events

Withdrawals

Study ID

Treatment

Any

Serious

Adverse event

Other

Bentley 1987

(1) Paracetamol+codeine 1000/60 mg, n=41

(2) Paracetamol 1000 mg, n=41

(3) Codeine 60 mg, n=21

(4) Placebo, n=17

(1) 15/42

(2) 21/42

(4) 9/19

No data

None reported

1 pt lost to follow up, 4 had invalid data

Bjune 1996

(1) Paracetamol+codeine 800/60 mg, n=50

(2) Paracetamol 1000 mg, n=50

(3) Placebo, n=25

(1) 10/50

(2) 10/50

(3) 1/25

None

None reported

6 paracetamol+codeine pts, 7 paracetamol pts, 4 placebo pts had invalid data

Bourne 2005

(1) Paracetamol+codeine 300/30 mg, n = 55

(2) Paracetamol+tramadol 325/37.5 mg, n = 49

(3) Placebo, n = 49

No single dose data

No single dose data

No single dose data

None

Breivik 1999

(1) Paracetamol+codeine 1000/60 mg n=24

(2) Paracetamol 1000mg, n=22

(3) Diclofenac 100 mg, n=22

(4) Paracetamol+diclofenac 1000/100 mg, n=24

(5) Paracetamol+diclofenac+codeine 1000/100/60 mg, n=24

(1) 13/23

(2) 3/24

None

None

1 pt in paracetamol+codeine group lost to follow up, 4 pts (2 paracetamol, 2 diclofenac) had invalid data

Chang 2001

(1) Paracetamol+codeine 600/60 mg n=180

(2) Rofecoxib 50 mg n=182

(3) Placebo n=31

At 24 hr:

(1) 83/180

(2) 10/31

None

None

6 pts lost to follow up, 1 para/codeine group vomited medication

Chang 2005

(1) Paracetamol+codeine 600/60 mg n=180

(2) Rofecoxib 50 mg n=180

(3) Placebo n=30

At 24 hr:

(1) 63/180

(3) 14/30

None

None

1 rofecoxib pt lost to follow up

Cooper 1981

(1) Paracet+codeine 650/60 mg, n=42

(2) Paracetamol 650 mg, n=37

(3) Paracetamol+d‐propoxyphene 650/100 mg, n=42

(4) Ibuprofen 200 mg, n=42

(5) Placebo, n=37

(1) 10/42

(2) 12/37

(5) 4/37

None

None

31 pts had invalid data

Cooper 1988

(1) Paracetamol+codeine 600/60 mg, n=31

(2) Paracetamol 600 mg, n=36

(3) Meclofenamate Na 100 mg, n=36

(4) Placebo, n=40

15 pts in total reported adverse events

None

None

11 pts lost to follow up, 3 had invalid data

Cooper 1991

(1) Paracetamol+codeine 650/60 mg, n=39

(2) Paracetamol 650 mg, n=37

(3) Zomepirac 100 mg, n=23

(4) Flurbiprofen 50 mg, n=42

(5) Flurbiprofen 100 mg, n=41

(6) Placebo, n=44

(1) 8/39

(2) 6/37

(6) 7/44

None

None reported

3 lost to follow up, 5 had invalid data

Desjardins 1986

(1) Paracetamol+codeine 300/30 mg, n=39

(2) Aspirin+butalbital+caffeine+codeine 325/50/40/30 mg, n=43

(3) Placebo, n=41

(1) 2/39

(3) 4/41

None

None

14 pts did not medicate, lost to follow up, invalid data

Dionne 1994

(1) Paracetamol+codeine 650/60 mg, n=24

(2) Paracetamol 650 mg, n=27

(3) Flurbiprofen 50 mg, n=25

(4) Flurbiprofen 100 mg, n=22

(5) Placebo, n=25

(1) 9/24

(2) 7/27

(5) 5/25

None

None reported

11 pts had invalid data

Forbes 1982

(1) Paracetamol+codeine 600/60 mg, n=31

(2) Paracetamol 600 mg, n=34

(3) Diflusinal 500 mg, n=32

(4) Diflusinal 1000 mg, n=32

(5) Placebo, n=30

15% in total reported adverse events

None

None

4 pts lost to follow up, 11 had invalid data

Forbes 1983

(1) Paracetamol+codeine 600/60 mg, n=26

(2) Paracetamol 600 mg, n=26

(3) Diflusinal 500 mg, n=26

(4) Diflusinal 1000 mg, n=28

(5) Placebo, n=26

(1) 11/26

(2) 11/26

(5) 4/26

None reported

None

None

Forbes 1986

(1) Paracetamol+codeine 300/30 mg, n=43

(2) Aspirin+butalbital+caffeine+codeine 325/50/40/15 mg, n=41

(3) Placebo, n=38

(1) 6/46

(2) 9/46

None

None

1 pt lost to follow up, 17 had invalid data

Forbes 1989

(1) Paracetamol+codeine 600/60 mg, n=17

(2) Paracetamol 600 mg, n=22

(3) Flurbiprofen 100 mg, n=26

(4) Placebo, n=23

(1) 1/17

(2) 3/26

(4) 2/26

None

None

10 pts had invalid data

Forbes 1990a

(1) Paracetamol+codeine 600/60 mg, n=27

(2) Aspirin 650 mg, n=32

(3) Ketorolac 10 mg, n=37

(4) Placebo, n=32

(1) 9/31

(4) 5/34

None

None

1 lost to follow up, 14 had invalid data

Forbes 1990b

(1) Paracetamol+codeine 600/60 mg, n=38

(2) Paracetamol 600 mg, n=36

(3) Ketorolac 10 mg, n=31

(4) Ketorolac 20 mg, n=35

(5) Ibuprofen 400 mg, n=32

(6) Placebo, n=34

(1) 8/40

(2) 5/41

(6) 0/38

None

None

3 pts lost to follow up, 27 had invalid data

Forbes 1994

(1) Paracetamol+codeine 300/30 mg, n=93

(2) Paracetamol+hydrocodone bitartrate 500/7.5 mg, n=94

(3) Placebo, n=45

(1) 18/107

(3) 10/65

None

None

1 pt lost to follow up, 59 had invalid data

Gertzbein 1986

(1) Paracetamol+codeine 1000/60 mg, n=45

(2) Paracetamol 1000 mg, n=45

(1) 13/47

(2) 13/46

None

None

1 pt withdrew consent, 2 pts had invalid data (2 paracetamol+codeine group, 1 paracetamol group)

Heidrich 1985

(1) Paracetamol+codeine 300/30 mg, n=40

(2) Ibuprofen 400 mg, n=40

(3) Placebo, n=40

No sig diff between groups

No data

None

No data

Honig 1984

(1) Paracetamol+codeine 600/60 mg, n=30

(2) Paracetamol 600 mg, n=28

(3) Codeine 60 mg, n=28

(4) Placebo, n = 30

No data

None reported

None reported

None reported

Malmstrom 2004

(1) Paracetamol+codeine 600/60 mg, n=50

(2) Etoricoxib 120 mg, n=50

(3) Naproxen sodium 550 mg, n=50

(4) Placebo, n=50

Within 10 days:

(1) 25/50

(4) 18/50

None

None

4 pts lost to follow up (2 paracetamol+codeine group, 1 placebo group)

Pande 1996a

(1) Paracetamol+codeine 600/60 mg, n=23

(2) Placebo, n=26

no data

None

None reported

None reported

Smith 2004

(1)Paracetamol+codeine 300/30 mg, n = 109

(2) Paracetamol+tramadol 325/37.5 mg, n = 98

(3) Placebo n = 98

No single dose data

No single dose data

No single dose data

1 pt had invalid data

Stubhaug 1995

(1) Paracetamol+codeine 1000/60 mg, n=36

(2) Tramadol 50 mg, n=33

(3) Tramadol 100 mg, n=35

(4) Placebo, n=33

(1) 10/37

(2) 15/36

None

None reported

7 pts had invalid data

Sunshine 1986

(1) Paracetamol+codeine 650/60 mg, n=31

(2) Paracetamol 650 mg, n=30

(3) Flurbiprofen 50 mg, n=31

(4) Flurbiprofen 100 mg, n=29

(5) Zomepirac 100 mg, n=31

(6) Placebo, n=30

(1) 3/31

(2) 1/30

(6) 1/30

None

None reported

None

Turek 1988

(1) Paracetamol+codeine 650/60 mg, n=39

(2) Ketoprofen 50 mg, n=41

(3) Ketoprofen 150 mg, n=39

(4) Placebo, n=41

(1) 11/39

(4) 4/41

None

None

1 placebo pt had invalid data

Ziccardi 2000

(1) Paracetamol+codeine 300/30 mg, n=49

(2) Ibuprofen+hydrocodone 200/75 mg, n=49

(3) Placebo, n= 27

(1) 21/49

(3) 6/27

None

No data

None reported
Figuras y tablas -
Table 2. Summary of outcomes ‐ adverse events and withdrawals
Ir a la tabla de la revisión
Comparison 1. Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

3

192

Risk Ratio (M‐H, Fixed, 95% CI)

6.34 [2.93, 13.73]

2 Participants with any adverse event Show forest plot

3

209

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.58, 1.39]
Figuras y tablas -
Comparison 1. Paracetamol 800 to 1000 mg plus codeine 60 mg versus placebo
Ir a la tabla de la revisión
Comparison 2. Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

4

304

Risk Ratio (M‐H, Fixed, 95% CI)

1.31 [1.06, 1.62]

2 Participants using rescue medication over 4 to 6 hours Show forest plot

2

127

Risk Ratio (M‐H, Fixed, 95% CI)

0.61 [0.41, 0.89]

3 Participants with any adverse event Show forest plot

4

324

Odds Ratio (M‐H, Fixed, 95% CI)

1.13 [0.70, 1.81]
Figuras y tablas -
Comparison 2. Paracetamol 800 to 1000 mg plus codeine 60 mg versus paracetamol 1000 mg
Ir a la tabla de la revisión
Comparison 3. Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

17

1413

Risk Ratio (M‐H, Fixed, 95% CI)

2.64 [2.17, 3.21]

2 Participants with at least 50% pain relief over 4 to 6 hours, dental Show forest plot

14

1221

Risk Ratio (M‐H, Fixed, 95% CI)

2.70 [2.18, 3.35]

3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery Show forest plot

3

192

Risk Ratio (M‐H, Fixed, 95% CI)

2.36 [1.49, 3.73]

4 Participants using rescue medication over 4 to 6 hours Show forest plot

10

657

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.68, 0.82]

5 Participants with any adverse event Show forest plot

14

1258

Risk Ratio (M‐H, Fixed, 95% CI)

1.57 [1.27, 1.93]
Figuras y tablas -
Comparison 3. Paracetamol 600 to 650 mg plus codeine 60 mg versus placebo
Ir a la tabla de la revisión
Comparison 4. Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

10

622

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.11, 1.52]

2 Participants with at least 50% pain relief over 4 to 6 hours, dental Show forest plot

8

512

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [1.11, 1.57]

3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery Show forest plot

2

110

Risk Ratio (M‐H, Fixed, 95% CI)

1.21 [0.83, 1.77]

4 Participants using rescue medication over 4 to 6 hours Show forest plot

7

436

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.64, 0.88]

5 Participants with any adverse event Show forest plot

7

443

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [0.79, 1.57]
Figuras y tablas -
Comparison 4. Paracetamol 600 to 650 mg plus codeine 60 mg versus paracetamol 600‐650 mg
Ir a la tabla de la revisión
Comparison 5. Paracetamol 300 mg plus codeine 30 mg versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

6

690

Risk Ratio (M‐H, Fixed, 95% CI)

1.87 [1.42, 2.47]

2 Participants with at least 50% pain relief over 4 to 6 hours, dental Show forest plot

3

299

Risk Ratio (M‐H, Fixed, 95% CI)

3.31 [1.76, 6.23]

3 Participants with at least 50% pain relief over 4 to 6 hours, other surgery Show forest plot

3

391

Risk Ratio (M‐H, Fixed, 95% CI)

1.51 [1.11, 2.05]

4 Participants using rescue medication over 4 to 6 hours Show forest plot

4

529

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.68, 0.91]

5 Participants with any adverse event Show forest plot

3

344

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.50, 1.45]
Figuras y tablas -
Comparison 5. Paracetamol 300 mg plus codeine 30 mg versus placebo
Ir a la tabla de la revisión
Comparison 6. Sensitivity analysis (paracetamol with codeine versus placebo)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fewer than 40 patients in active and placebo groups, participants with at least 50% pain relief over 4 to 6 hours Show forest plot

10

572

Risk Ratio (M‐H, Fixed, 95% CI)

3.01 [2.31, 3.92]

2 More than 40 patients in active and placebo groups, participants with at least 50% pain relief over 4 to 6 hours Show forest plot

5

629

Risk Ratio (M‐H, Fixed, 95% CI)

1.57 [1.21, 2.03]
Figuras y tablas -
Comparison 6. Sensitivity analysis (paracetamol with codeine versus placebo)
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Comparison 7. Sensitivity analysis (paracetamol with codeine versus paracetamol)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fewer than 40 patients in active and control groups, Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

10

588

Risk Ratio (M‐H, Fixed, 95% CI)

1.36 [1.15, 1.60]

2 More than 40 patients in active and control groups, Participants with at least 50% pain relief over 4 to 6 hours Show forest plot

3

259

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.02, 1.65]
Figuras y tablas -
Comparison 7. Sensitivity analysis (paracetamol with codeine versus paracetamol)
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Comparison 8. Paracetamol plus codeine (all doses) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with any adverse event Show forest plot

20

1811

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [1.15, 1.63]
Figuras y tablas -
Comparison 8. Paracetamol plus codeine (all doses) versus placebo
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Comparison 9. Paracetamol plus codeine (all doses) versus paracetamol alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with any adverse event Show forest plot

11

767

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [0.87, 1.40]
Figuras y tablas -
Comparison 9. Paracetamol plus codeine (all doses) versus paracetamol alone
Ir a la tabla de la revisión