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. |