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. 2017 May 25;2017(5):CD007355. doi: 10.1002/14651858.CD007355.pub3
Study ID Treatment Adverse events Withdrawals
Any Serious Adverse event Other
Akural 2009 (1) Ketoprofen 100 mg, n = 20
(2) Paracetamol 1000 mg, n = 18
(3) Ketoprofen 100 mg + paracetamol 1000 mg, n = 20
(4) Placebo, n = 20
No usable data
Nausea within 10 h:
(1) 4/20
(3) 4/20
(4) 3/20
4‐6 "unrousable or moderately sedated " participants in each of the 4 treatment arms (n = 18‐20), with the maximum number within 1.5 h from dosing
None None 4 exclusions due to protocol violations
Arnold 1990 (1) Ketoprofen 25 mg, n = 14
(2) Ketoprofen 100 mg, n = 16
(3) Ibuprofen 400 mg, n = 15
(4) Placebo, n = 14
At 6 h:
(1) 3/14
(2) 6/16
(4) 3/14
None (1) 1/14 (nausea and dizziness after 1 h) None reported
Balzanelli 1996 (1) Ketoprofen lysine 80 mg, n = 30
(2) Placebo, n = 30
No usable data None reported None None
Cooper 1984 (1) Ketoprofen 25 mg, n = 30
(2) Ketoprofen 50 mg, n = 31
(3) Ketoprofen 100 mg, n = 31
(4) Aspirin 650 mg, n = 31
(5) Placebo, n = 31
At 6 h:
(1) 7/30
(2) 10/31
(3) 9/31
(5) 6/30
None None Exclusions due to not taking medication, protocol violations and loss to follow‐up:
(1) 6
(2) 5
(3) 5
(4) 6
(5) 6
Cooper 1988 (1) Ketoprofen 25 mg, n = 42
(2) Ketoprofen 100 mg, n = 39
(3) Ibuprofen 400 mg, n = 37
(4) Placebo, n = 43
At 6 h:
(1) 8/44
(2) 4/39
(4) 7/45
None reported None reported 20 exclusions: 13 lost to follow‐up and 7 protocol violations
Cooper 1998 (1) Dexketoprofen 25 mg, n = 50
(2) Dexketoprofen 100 mg, n = 51
(3) Paracetamol 1000 mg, n = 50
(4) Placebo, n = 26
At 6 h:
(1) 22/50
(2) 16/51
(4) 4/26
None None None
Gay 1996 (1) Dexketoprofen 5 mg, n = 41
(2) Dexketoprofen 10 mg, n = 42
(3) Dexketoprofen 20 mg, n = 41
(4) Ibuprofen 400 mg, n = 41
(5) Placebo, n = 41
At 6 h:
(1) 3/41
(2) 2/42
(3) 5/41
(5) 4/39
None None 2 exclusions in placebo group due to early remedication
Harrison 1996 (1) Dexketoprofen 12.5 mg, n = 49
(2) Dexketoprofen 25 mg, n = 46
(3) Placebo, n = 46
At 6 h:
(1) 6/49
(2) 7/46
(3) 6/46
None (1) 0/49
(2) 1/46
(3) 1/46
6 exclusions due to protocol violations
Jackson 2004 (1) Dexketoprofen 25 mg, n = 42
(2) Rofecoxib 50 mg, n = 38
(3) Placebo, n = 43
At 24 h:
(1) 5/42
(3) 4/41
None None 3 participants excluded from analyses: 2 in placebo group lost to follow‐up, 1 in rofecoxib group did not take medication
McGurk 1998 (1) Ketoprofen 50 mg, n = 43
(2) Dexketoprofen 12.5 mg, n = 44
(3) Dexketoprofen 25 mg, n = 41
(4) Dexketoprofen 50 mg, n = 43
(5) Placebo, n = 39
At 6 h:
(1) 5/43
(2) 4/41
(3) 4/41
(4) 7/43
(5) 8/39
None (1) 0/42
(2) 0/44
(3) 0/41
(4) 1/43
(5) 1/39
10 participants excluded from efficacy analyses due to early remedication or loss to follow‐up:
(1) 3
(2) 3
(3) 1
(4) 1
(5) 2
McQuay 2016 (1) Dexketoprofen 25 mg, n = 161
(2) Tramadol 100 mg, n = 160
(3) Dexketoprofen 25 mg + tramadol 75 mg, n = 159
(4) Placebo, n = 161
No usable data None during single dose phase
Over 5 days:
(1) 1/213 (4 events)
(2) 0/212
(3) 1/213 (1 event)
None (1) 1/161 (withdrawal by subject)
(2) 0/160
(3) 0/159
(4) 2/161 (withdrawal by subject, protocol violation)
Mehlisch 1984 (1) Ketoprofen 25 mg, n = 24
(2) Ketoprofen 50 mg, n = 27
(3) Ketoprofen 100 mg, n = 27
(4) Codeine 90 mg, n = 27
(5) Placebo, n = 24
At 6 h:
54 participants in total
None reported None reported 9 participants received medication but were not included in analysis. Reasons and groups not given.
Moore 2015c (1) Dexketoprofen 12.5 mg, n = 60
(2) Dexketoprofen 25 mg, n = 61
(3) Tramadol 37.5 mg, n = 59
(4) Tramadol 75 mg, n = 59
(5) Dexketoprofen 12.5 mg + tramadol 37.5 mg, n = 60
(6) Dexketoprofen 12.5 mg + tramadol 75 mg, n = 62
(7) Dexketoprofen 25 mg + tramadol 37.5 mg, n = 63
(8) Dexketoprofen 25 mg + tramadol 75 mg, n = 61
(9) Ibuprofen 400 mg, n = 60
(10) Placebo, n = 62
Within 24 h:
(1) 1/60
(2) 3/61
(10) 0/62
(1) 0/60
(2) 0/61
(10) 0/62
(1) 0/60
(2) 0/61
(10) 0/62
(1) 0/60
(2) 0/61
(10) 0/62
Moore 2016 (1) Dexketoprofen 25 mg, n = 151
(2) Tramadol 100 mg, n = 150
(3) Dexketoprofen 25 mg + tramadol 75 mg, n = 152
(4) Placebo, n = 153
No usable data No usable data No usable data No usable data
Olson 1999 (1) Ketoprofen liquid 25 mg, n = 28
(2) Ketoprofen liquid 50 mg, n = 26
(3) Dipyrone liquid 500 mg, n = 27
(4) Placebo, n = 27
No adverse events reported None None None
Olson 2001 (1) Ketoprofen 25 mg, n = 67
(2) Ibuprofen liquigel 400 mg, n = 67
(3) Paracetamol 1000 mg, n = 66
(4) Placebo, n = 39
At 6 h:
(1) 5/67
(4) 2/39
None None None
Schreiber 1996 (1) Ketoprofen 50 mg, n = 54
(2) Dexketoprofen 12.5 mg, n = 52
(3) Dexketoprofen 25 mg, n = 52
(4) Placebo, n = 55
No single dose data None Multiple dose:
(1) 0/54
(2) 1/52
(3) 2/52
(4) 1/55
Multiple dose (includes successful therapy):
(1) 35/54
(2) 36/52
(3) 35/52
(4) 39/55
Seymour 1996 (1) Ketoprofen 12.5 mg, n = 42
(2) Ketoprofen 25 mg, n = 41
(3) Paracetamol 500 mg, n = 41
(4) Paracetamol 1000 mg, n = 41
(5) Placebo, n = 41
At 6 h:
(1) 0/42
(2) 0/41
(5) 0/41
None None Exclusions due to early remedication:
(1) 2
(3) 1
(4) 1
(5) 2
Seymour 2000 (1) Buffered ketoprofen 12.5 mg, n = 61
(2) Ibuprofen 200 mg, n = 59
(3) Placebo, n = 60
At 6 h:
(1) 2/61
(3) 3/60
None None Exclusions due to protocol violations:
(2) 1
(3) 1
Sunshine 1988 (1) Ketoprofen 50 mg, n = 32
(2) Ketoprofen 150 mg, n = 31
(3) Paracetamol 650 mg + codeine 60 mg, n = 28
(4) Placebo, n = 32
At 6 h:
(1) 2/32
(3) 1/32
None None None
Sunshine 1993 (1) Ketoprofen 50 mg, n = 48
(2) Ketoprofen 100 mg, n = 48
(3) Paracetamol 650 mg, n = 48
(4) Paracetamol 650 mg + oxycodone 10 mg, n = 48
(5) Placebo, n = 48
No single dose data "No cases of possible clinical concern" (multiple dose included) None None
Sunshine 1998 (1) Ketoprofen 6.25 mg, n = 35
(2) Ketoprofen 12.5 mg, n = 35
(3) Ketoprofen 25 mg, n = 35
(4) Ibuprofen 200 mg, n = 35
(5) Placebo, n = 35
At 6 h:
(1) 3/35
(2) 6/35
(3) 3/35
(5) 3/35
None None Exclusions due to early remedication, protocol violation:
(2) 1
(3) 1
(5) 2
Turek 1988 (1) Ketoprofen 50 mg, n = 41
(2) Ketoprofen 150 mg, n = 39
(3) Paracetamol 650 mg + codeine 60 mg, n = 39
(4) Placebo, n = 42
At 6 h:
(1) 14/41
(2) 8/39
(3) 4/41
None None 1 exclusion in placebo group due to protocol violation.
Vidal 1999 (1) Ketoprofen 50 mg, n = 47
(2) Dexketoprofen 12.5 mg, n = 47
(3) Dexketoprofen 25 mg, n = 47
(4) Placebo, n = 47
No single dose data None Multiple dose:
(1) 0/43
(2) 1/45
(3) 1/41
(4) 2/43
Multiple dose:
(1) 0/43
(2) 2/45
(3) 2/41
(4) 3/43
h: hour.