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Forest plot of comparison: 2 Parecoxib 20 mg vs. Placebo, outcome: 2.1 Participants with at least 50% pain relief.
Figuras y tablas -
Figure 1

Forest plot of comparison: 2 Parecoxib 20 mg vs. Placebo, outcome: 2.1 Participants with at least 50% pain relief.

Forest plot of comparison: 3 Parecoxib 40 mg vs. Placebo, outcome: 3.1 Participants with at least 50% pain relief.
Figuras y tablas -
Figure 2

Forest plot of comparison: 3 Parecoxib 40 mg vs. Placebo, outcome: 3.1 Participants with at least 50% pain relief.

Forest plot of comparison: 4 Parecoxib (20 to 40 mg) vs. Placebo, outcome: 4.1 Number of participants using rescue medication in 24 h.
Figuras y tablas -
Figure 3

Forest plot of comparison: 4 Parecoxib (20 to 40 mg) vs. Placebo, outcome: 4.1 Number of participants using rescue medication in 24 h.

Forest plot of comparison: 2 Parecoxib 20 mg vs. Placebo, outcome: 2.3 Number or participants with any adverse event.
Figuras y tablas -
Figure 4

Forest plot of comparison: 2 Parecoxib 20 mg vs. Placebo, outcome: 2.3 Number or participants with any adverse event.

Forest plot of comparison: 3 Parecoxib 40 mg vs. Placebo, outcome: 3.3 Number of participants with any adverse event.
Figuras y tablas -
Figure 5

Forest plot of comparison: 3 Parecoxib 40 mg vs. Placebo, outcome: 3.3 Number of participants with any adverse event.

Comparison 1 Parecoxib 20 mg vs. Placebo, Outcome 1 Participants with at least 50% pain relief.
Figuras y tablas -
Analysis 1.1

Comparison 1 Parecoxib 20 mg vs. Placebo, Outcome 1 Participants with at least 50% pain relief.

Comparison 1 Parecoxib 20 mg vs. Placebo, Outcome 2 Number of participants using rescue medication in 24 hrs.
Figuras y tablas -
Analysis 1.2

Comparison 1 Parecoxib 20 mg vs. Placebo, Outcome 2 Number of participants using rescue medication in 24 hrs.

Comparison 1 Parecoxib 20 mg vs. Placebo, Outcome 3 Number of participants with any adverse event.
Figuras y tablas -
Analysis 1.3

Comparison 1 Parecoxib 20 mg vs. Placebo, Outcome 3 Number of participants with any adverse event.

Comparison 2 Parecoxib 40 mg vs. Placebo, Outcome 1 Participants with at least 50% pain relief.
Figuras y tablas -
Analysis 2.1

Comparison 2 Parecoxib 40 mg vs. Placebo, Outcome 1 Participants with at least 50% pain relief.

Comparison 2 Parecoxib 40 mg vs. Placebo, Outcome 2 Number or participants using rescue medication in 24 hrs.
Figuras y tablas -
Analysis 2.2

Comparison 2 Parecoxib 40 mg vs. Placebo, Outcome 2 Number or participants using rescue medication in 24 hrs.

Comparison 2 Parecoxib 40 mg vs. Placebo, Outcome 3 Number of participants with any adverse event.
Figuras y tablas -
Analysis 2.3

Comparison 2 Parecoxib 40 mg vs. Placebo, Outcome 3 Number of participants with any adverse event.

Comparison 3 Parecoxib (20 to 40 mg) vs. Placebo, Outcome 1 Number of participants using rescue medication in 24 hrs.
Figuras y tablas -
Analysis 3.1

Comparison 3 Parecoxib (20 to 40 mg) vs. Placebo, Outcome 1 Number of participants using rescue medication in 24 hrs.

Table 1. Summary of Outcomes: analgesia and use of rescue medication

Analgesia

Rescue medication

Study ID

Treatment

PR

Number with 50% PR

PGE: very good or excellent

Time to use (h)

% using

Barton 2002

(1) Parecoxib 20 mg IV, n = 39

(2) Parecoxib 40 mg IV, n = 38

(3) Ketorolac 30 mg IV, n = 41

(4) Morphine 4 mg IV, n = 42

(5) Placebo, n = 42

TOTPAR 6:

(1) 10.9

(2) 11.4

(5) 4.2

(1) 18/38

(2) 20/38

(5) 5/39

No usable data

(1) 6.2

(2) 6.5

(5) 1.8

at 24 h:

(1) 92

(2) 87

(5) 97

Bikhazi 2004

(1) Parecoxib 20 mg IV, n = 40

(2) Parecoxib 40 mg IV, n = 41

(3) Ketorolac 30 mg IV, n = 42

(4) Morphine 4 mg IV, n = 40

(5) Placebo, n = 45

TOTPAR 6:

(1) 12.0

(2) 15.4

(5) 8.0

(1) 21/38

(2) 30/41

(5) 14/44

No usable data

(1) 6.1

(2) 6.3

(5) 2.8

at 6 h:

(1) 37

(2) 32

(5) 71

Daniels 2001

(1) Parecoxib 20 mg IM, n = 51

(2) Parecoxib 20 mg IV, n = 50

(3) Parecoxib 40 mg IM, n = 50

(4) Parecoxib 40 mg IV, n = 51

(5) Ketorolac 60 mg IM, n = 51

(6) Placebo, n = 51

TOTPAR 6:

(1) 12.6

(2) 12.4

(3) 15.1

(4) 13.8

(6) 2.7

(1) 30/51

(2) 29/50

(3) 36/50

(4) 33/51

(6) 2/51

No usable data

(1) 9.3

(2) 7.1

(3) 21.7

(4) 15.7

(6) 1.1

at 24 h:

(1) 76

(2) 80

(3) 50

(4) 53

(6) 94

Malan 2005

(1) Parecoxib 40 mg IM, n = 62

(2) Morphine 6 mg IM, n = 70

(3) Morphine 12 mg IM, n = 62

(4) Placebo, n = 70

TOTPAR 6:

(1) 13.3

(4) 5.8

(1) 39/62

(4) 14/70

No usable data

(1) 5.9

(4) 2.2

at 12 h:

(1) 79

(4) 99

at 6 h:

(1) 49

(4) 90

Mehlisch 2003

(1) Parecoxib 1 mg IV, n = 51

(2) Parecoxib 2 mg IV, n = 51

(3) Parecoxib 5 mg IV, n = 51

(4) Parecoxib 10 mg IV, n = 51

(5) Parecoxib 20 mg IV, n = 51

(6) Parecoxib 50 mg IV, n = 51

(7) Parecoxib 100 mg IV, n = 51

(8) Ketorolac 30 mg IV, n = 50

(9) Placebo, n = 50

TOTPAR 6:

(1) 3.8

(2) 3.4

(3) 8.7

(4) 8.7

(5) 12.3

(6) 12.6

(7) 13

(9) 1.8

(1) 5/51

(2) 4/51

(3) 19/51

(4) 19/51

(5) 28/50

(6) 30/51

(7) 31/51

(9) 0/50

No usable data

(1) 1.1

(2) 1.1

(3) 3.1

(4) 2.2

(5) 8.0

(6) 10.6

(7) 13.5

(9) 1.0

at 24 h:

(1) 98

(2) 96

(3) 80

(4) 90

(5) 80

(6) 57

(7) 55

(9) 98

Mehlisch 2004

(1) Parecoxib 1 mg IM, n = 51

(2) Parecoxib 2 mg IM, n = 50

(3) Parecoxib 5 mg IM, n = 51

(4) Parecoxib 10 mg IM, n = 50

(5) Parecoxib 20 mg IM, n = 50

(6) Ketorolac 30 mg IM, n = 51

(7) Placebo, n = 50

TOTPAR 6:

(1) 4.67

(2) 6.37

(3) 6.11

(4) 7.61

(5) 12.6

(7) 2.93

(1) 7/51

(2) 12/50

(3) 11/51

(4) 15/49

(5) 29/50

(7) 2/50

No usable data

(1) 1.53

(2) 1.57

(3) 1.53

(4) 4.07

(5) 7.68

(7) 1.05

at 24 h:

(1) 84

(2) 84

(3) 84

(4) 92

(5) 66

(7) 86

Rasmussen 2002

(1) Parecoxib 20 mg IV, n = 43

(2) Parecoxib 40 mg IV, n = 42

(3) Ketorolac 30 mg IV, n = 42

(4) Morphine 4 mg IV, n = 42

(5) Placebo, n = 39

TOTPAR 6:

(1) 7.89

(2) 10.81

(5) 5.19

(1) 14/43

(2) 17/36

(5) 6/37

No usable data

(1) 3.15

(2) 5.17

(5) 1.8

at 24 h:

(1) 95

(2) 86

(5) 100

IM ‐ intramuscular; IV ‐ intravenous

Figuras y tablas -
Table 1. Summary of Outcomes: analgesia and use of rescue medication
Table 2. Summary of Outcomes: adverse events and withdrawals

Adverse events

Withdrawals

Study ID

Treatment

Any

Serious

Adverse event

Other

Barton 2002

(1) Parecoxib 20 mg IV, n = 39

(2) Parecoxib 40 mg IV, n = 38

(3) Ketorolac 30 mg IV, n = 41

(4) Morphine 4 mg IV, n = 42

(5) Placebo, n = 42

(1) 34/39

(2) 32/38

(5) 31/42

None related to study medication
but 2 in (4)

(1) 5/39

(2) 4/38

(5) 2/42

4 pts excluded from efficacy analysis: 3 pts in (5) before completing 1 hr assessment and 1 pt in (1) due to protocol violation

Bikhazi 2004

(1) Parecoxib 20 mg IV, n = 40

(2) Parecoxib 40 mg IV, n = 41

(3) Ketorolac 30 mg IV, n = 42

(4) Morphine 4 mg IV, n = 40

(5) Placebo, n = 45

No single dose data

None related to study medication

No single dose data

5 pts excluded from efficacy analysis: 1 had inadequate baseline pain, 4 used rescue med within 1 h

Daniels 2001

(1) Parecoxib 20 mg IM, n = 51

(2) Parecoxib 20 mg IV, n = 50

(3) Parecoxib 40 mg IM, n = 50

(4) Parecoxib 40 mg IV, n = 51

(5) Ketorolac 60 mg IM, n = 51

(6) Placebo, n = 51

(1) 14/51

(2) 21/50

(3) 17/50

(4) 20/51

(6) 18/51

None related to dose or route of study medication

None reported

None

1 pt in (6) excluded due to non‐compliance

Malan 2005

(1) Parecoxib 40 mg IM, n = 62

(2) Morphine 6 mg IM, n = 70

(3) Morphine 12 mg IM, n = 62

(4) Placebo, n = 70

(1) 36/62

(4) 41/70

Related to study medication

(1) 19/62

(4) 28/70

None

(1) 1/62

14 pts excluded from efficacy analysis: protocol violation, failed inclusion and exclusion criteria, used rescue med within 1 h, missing consecutIVe PR scores

Mehlisch 2003

(1) Parecoxib 1 mg IV, n = 51

(2) Parecoxib 2 mg IV, n = 51

(3) Parecoxib 5 mg IV, n = 51

(4) Parecoxib 10 mg IV, n = 51

(5) Parecoxib 20 mg IV, n = 51

(6) Parecoxib 50 mg IV, n = 51

(7) Parecoxib 100 mg IV, n = 51

(8) Ketorolac 30 mg IV, n = 50

(9) Placebo, n = 50

(1) 30/51

(2) 32/51

(3) 28/51

(4) 25/51

(5) 25/51

(6) 25/51

(7) 28/51

(9) 27/50

None

None

3 pts excluded from efficacy analysis, 1 in (5) and 2 in (8), due to infiltration of study medication into surrounding tissue during administration

Mehlisch 2004

(1) Parecoxib 1 mg IM, n = 51

(2) Parecoxib 2 mg IM, n = 50

(3) Parecoxib 5 mg IM, n = 51

(4) Parecoxib 10 mg IM, n = 50

(5) Parecoxib 20 mg IM, n = 50

(6) Ketorolac 30 mg IM, n = 51

(7) Placebo, n = 50

(1) 25/51

(2) 21/50

(3) 30/51

(4) 28/50

(5) 25/50

(7) 26/50

None

None

2 pts excluded: 1 in (4) and 1 in (6), due to protocol violation

Rasmussen 2002

(1) Parecoxib 20 mg IV, n = 43

(2) Parecoxib 40 mg IV, n = 42

(3) Ketorolac 30 mg IV, n = 42

(4) Morphine 4 mg IV, n = 42

(5) Placebo, n = 39

(1) 31/43

(2) 25/42

(5) 24/39

None related to study medication

(2) 1/42

10 pts excluded: 5 due to non‐compliance after administration of study medication; 4 due to protocol violation; 1 due to administration of the wrong dose of parecoxib

IM ‐ intramuscular; IV ‐ intravenous; pt ‐ participant

Figuras y tablas -
Table 2. Summary of Outcomes: adverse events and withdrawals
Comparison 1. Parecoxib 20 mg vs. Placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief Show forest plot

6

591

Risk Ratio (M‐H, Fixed, 95% CI)

5.11 [3.51, 7.43]

1.1 Intramuscular route

2

177

Risk Ratio (M‐H, Fixed, 95% CI)

14.82 [4.77, 46.06]

1.2 Intravenous route

5

414

Risk Ratio (M‐H, Fixed, 95% CI)

3.88 [2.61, 5.75]

2 Number of participants using rescue medication in 24 hrs Show forest plot

5

491

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.80, 0.91]

3 Number of participants with any adverse event Show forest plot

5

516

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.89, 1.22]

Figuras y tablas -
Comparison 1. Parecoxib 20 mg vs. Placebo
Comparison 2. Parecoxib 40 mg vs. Placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with at least 50% pain relief Show forest plot

5

519

Risk Ratio (M‐H, Fixed, 95% CI)

3.89 [2.85, 5.31]

1.1 Intramuscular route

2

208

Risk Ratio (M‐H, Fixed, 95% CI)

4.56 [2.71, 7.69]

1.2 Intravenous route

4

311

Risk Ratio (M‐H, Fixed, 95% CI)

3.51 [2.39, 5.16]

2 Number or participants using rescue medication in 24 hrs Show forest plot

3

283

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.64, 0.79]

3 Number of participants with any adverse event Show forest plot

4

445

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.88, 1.21]

Figuras y tablas -
Comparison 2. Parecoxib 40 mg vs. Placebo
Comparison 3. Parecoxib (20 to 40 mg) vs. Placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants using rescue medication in 24 hrs Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Parecoxib 20 mg

5

491

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.80, 0.91]

1.2 Parecoxib 40 mg

3

283

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.64, 0.79]

Figuras y tablas -
Comparison 3. Parecoxib (20 to 40 mg) vs. Placebo