Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults

Helen Gaskell; Sheena Derry; Philip J Wiffen; R Andrew Moore

doi:10.1002/14651858.CD007355.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Forest plot of comparison: 3 Ketoprofen 50 mg versus placebo, outcome: 3.1 Participants with at least 50% pain relief over four to six hours.

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Figure 4

Ketoprofen 50 mg: percent of participants with at least 50% pain relief over four to six hours. Size of circle is proportional to size of study (inset scale). Dental studies: yellow; bunionectomy study: dark blue; other non‐dental studies: light blue.

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Figure 5

Forest plot of comparison: 6 Dexketoprofen 20 mg or 25 mg versus placebo, outcome: 6.1 Participants with at least 50% pain relief over four to six hours.

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Figure 6

Dexketoprofen 20/25 mg: percent of participants with at least 50% pain relief over four to six hours. Size of circle is proportional to size of study (inset scale). Dental studies: yellow; bunionectomy study: dark blue; other non‐dental studies: light blue.

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Analysis 1.1

Comparison 1 Ketoprofen 12.5 mg versus placebo, Outcome 1 Participants with ≥ 50% pain relief over 6 hours.

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Analysis 1.2

Comparison 1 Ketoprofen 12.5 mg versus placebo, Outcome 2 Participants using rescue medication over 6 hours.

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Analysis 1.3

Comparison 1 Ketoprofen 12.5 mg versus placebo, Outcome 3 Participants with any adverse event.

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Analysis 2.1

Comparison 2 Ketoprofen 25 mg versus placebo, Outcome 1 Participants with ≥ 50% pain relief over 6 hours.

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Analysis 2.2

Comparison 2 Ketoprofen 25 mg versus placebo, Outcome 2 Participants using rescue medication over 6 hours.

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Analysis 2.3

Comparison 2 Ketoprofen 25 mg versus placebo, Outcome 3 Participants with any adverse event.

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Analysis 3.1

Comparison 3 Ketoprofen 50 mg versus placebo, Outcome 1 Participants with ≥ 50% pain relief over 4‐6 hours.

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Analysis 3.2

Comparison 3 Ketoprofen 50 mg versus placebo, Outcome 2 Participants using rescue medication over 6‐8 hours.

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Analysis 3.3

Comparison 3 Ketoprofen 50 mg versus placebo, Outcome 3 Participants with any adverse event.

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Analysis 4.1

Comparison 4 Ketoprofen 80 mg or 100 mg versus placebo, Outcome 1 Participants with ≥ 50% pain relief.

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Analysis 4.2

Comparison 4 Ketoprofen 80 mg or 100 mg versus placebo, Outcome 2 Participants using rescue medication over 6‐8 hours.

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Analysis 4.3

Comparison 4 Ketoprofen 80 mg or 100 mg versus placebo, Outcome 3 Participants with any adverse event.

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Analysis 5.1

Comparison 5 Dexketoprofen 10 mg or 12.5 mg versus placebo, Outcome 1 Participants with ≥ 50% pain relief over 4‐6 hours.

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Analysis 5.2

Comparison 5 Dexketoprofen 10 mg or 12.5 mg versus placebo, Outcome 2 Participants using rescue medication over 6‐8 hours.

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Analysis 5.3

Comparison 5 Dexketoprofen 10 mg or 12.5 mg versus placebo, Outcome 3 Participants with any adverse event.

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Analysis 6.1

Comparison 6 Dexketoprofen 20 mg or 25 mg versus placebo, Outcome 1 Participants with ≥ 50% pain relief over 4‐6 hours.

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Analysis 6.2

Comparison 6 Dexketoprofen 20 mg or 25 mg versus placebo, Outcome 2 Participants using rescue medication over 6‐8 hours.

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Analysis 6.3

Comparison 6 Dexketoprofen 20 mg or 25 mg versus placebo, Outcome 3 Participants with any adverse event.

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Summary of findings for the main comparison. Ketoprofen 25 mg compared with placebo for acute postoperative pain

Ketoprofen 25 mg compared with placebo for acute postoperative pain
Patient or population: adults with moderate or severe acute postoperative pain Settings: clinic or hospital Intervention: ketoprofen 25 mg Comparison: placebo
Outcomes	Probable outcome with intervention	Probable outcome with placebo	RR, NNT, NNTp, or NNH (95% CI)	Number of studies, participants, or events	Quality of the evidence (GRADE)	Comments
Participants with ≥ 50% pain relief over 6 hours	620 in 1000	120 in 1000	RR 4.9 (3.5 to 6.9) NNT 2.0 (1.8 to 2.3)	8 studies 535 participants	High quality	Good quality studies, important outcome available, robust numbers.
Median (mean) time to use of rescue medication	5.3 hours (4.6 hours)	1.6 hours (2.5 hours)	Not estimated	2 studies 188 participants (5 studies 277 participants)	Very low quality	Small numbers of participants.
Participants using rescue medication over 6 hours	460 in 1000	79 in 1000	RR 0.60 (0.52 to 0.69) NNTp 3.0 (2.4 to 4.1)	6 studies 402 participants	Moderate	Modest numbers of participants and events.
Participants with ≥ 1 adverse event following a single dose	100 in 1000	91 in 1000	RR 1.2 (0.68 to 2.0) NNH not calculated	7 studies 490 participants	High quality	Good quality studies, important outcome available, robust numbers.
Participants with a serious adverse event following a single dose	No serious adverse events reported		Not estimated	8 studies 535 participants	Very low quality	No events in single dose studies not designed to evaluate serious but rare adverse events.
CI: confidence interval; NNH: number needed to treat for an additional harmful outcome; NNT: number needed to treat for an additional beneficial outcome; NNTp: number needed to treat to prevent an additional outcome: RR: risk ratio.
We used the following descriptors for levels of evidence (EPOC 2015). High: this research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different^a is low. Moderate: this research provides a good indication of the likely effect. The likelihood that the effect will be substantially different^a is moderate. Low: this research provides some indication of the likely effect. However, the likelihood that it will be substantially different^a is high. Very low: this research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different^a is very high. ^a Substantially different: a large enough difference that it might affect a decision.

Summary of findings for the main comparison. Ketoprofen 25 mg compared with placebo for acute postoperative pain

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Summary of findings 2. Ketoprofen 50 mg compared with placebo for acute postoperative pain

Ketoprofen 50 mg compared with placebo for acute postoperative pain
Patient or population: adults with moderate or severe acute postoperative pain Settings: clinic or hospital Intervention: ketoprofen 50 mg Comparison: placebo
Outcomes	Probable outcome with intervention	Probable outcome with placebo	RR, NNT, NNTp, or NNH (95% CI)	Number of studies, participants, or events	Quality of the evidence (GRADE)	Comments
Participants with ≥ 50% pain relief over 4‐6 hours	570 in 1000	230 in 1000	RR 2.5 (2.0 to 3.1) NNT 2.9 (2.4 to 3.7)	8 studies 594 participants	High quality	Good quality studies, important outcome available, robust numbers.
Median (mean) time to use of rescue medication	Approximately 5 hours (3.4 hours)	Approximately 3 hours (2.5 hours)	Not estimated	1 study 77 participants (5 studies, 342 participants)	Very low quality	Small numbers of participants.
Participants using rescue medication over 6 hours	320 in 1000	750 in 1000	RR 0.42 (0.33 to 0.52) NNTp 2.3 (1.8 to 3.1)	4 studies 263 participants	High quality	Reasonable numbers of participants and high event rate.
Participants with ≥ 1 adverse event following a single dose	180 in 1000	110 in 1000	RR 1.6 (0.98 to 2.8) NNH not calculated	5 studies 342 participants	High quality	Good quality studies, important outcome available, robust numbers.
Participants with a serious adverse event following a single dose	No serious adverse events reported		Not estimated	9 studies 688 participants	Very low quality	No events in single dose studies not designed to evaluate serious but rare adverse events
CI: confidence interval; NNH: number needed to treat for an additional harmful outcome; NNT: number needed to treat for an additional beneficial outcome; NNTp: number needed to treat to prevent an additional outcome: RR: risk ratio.
We used the following descriptors for levels of evidence (EPOC 2015). High: this research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different^a is low. Moderate: this research provides a good indication of the likely effect. The likelihood that the effect will be substantially different^a is moderate. Low: this research provides some indication of the likely effect. However, the likelihood that it will be substantially different^a is high. Very low: this research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different^a is very high. ^a Substantially different: a large enough difference that it might affect a decision.

Summary of findings 2. Ketoprofen 50 mg compared with placebo for acute postoperative pain

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Summary of findings 3. Dexketoprofen 10 mg‐12.5 mg compared with placebo for acute postoperative pain

Dexketoprofen 10 mg‐12.5 mg compared with placebo for acute postoperative pain
Patient or population: adults with moderate or severe acute postoperative pain Settings: clinic or hospital Intervention: dexketoprofen 10 mg‐12.5 mg Comparison: placebo
Outcomes	Probable outcome with intervention	Probable outcome with placebo	RR, NNT, NNTp, or NNH (95% CI)	Number of studies, participants, or events	Quality of the evidence (GRADE)	Comments
Participants with ≥ 50% pain relief over 4‐6 hours	440 in 1000	180 in 1000	RR 2.4 (1.8 to 3.3) NNT 3.9 (3.0 to 5.7)	5 studies 480 participants	High quality	Good quality studies, important outcome available, robust numbers.
Median (mean) time to use of rescue medication	3.6 hours (4.9 hours)	1.4 hours (3.6 hours)	Not estimated	1 study 122 participants (3 studies 253 participants)	Very low quality	Small numbers of participants.
Participants using rescue medication over 6 hours	490 in 1000	680 in 1000	RR 0.73 (0.61 to 0.86) NNTp 5.3 (3.5 to 11)	4 studies 373 participants	High quality	Reasonable numbers of participants and high event rate.
Participants with ≥ 1 adverse event following a single dose	68 in 1000	96 in 1000	RR 0.70 (0.36 to 1.4) NNH not calculated	4 studies 380 participants	High quality	Good quality studies, important outcome available, robust numbers.
Participants with a serious adverse event following a single dose	No serious adverse events reported		Not estimated	6 studies 574 participants	Very low quality	No events in single dose studies not designed to evaluate serious but rare adverse events.
CI: confidence interval; NNH: number needed to treat for an additional harmful outcome; NNT: number needed for an additional beneficial outcome; NNTp: number needed to treat to prevent an additional outcome: RR: risk ratio.
We used the following descriptors for levels of evidence (EPOC 2015). High: this research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different^a is low. Moderate: this research provides a good indication of the likely effect. The likelihood that the effect will be substantially different^a is moderate. Low: this research provides some indication of the likely effect. However, the likelihood that it will be substantially different^a is high. Very low: this research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different^a is very high. ^a Substantially different: a large enough difference that it might affect a decision.

Summary of findings 3. Dexketoprofen 10 mg‐12.5 mg compared with placebo for acute postoperative pain

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Summary of findings 4. Dexketoprofen 20 mg or 25 mg compared with placebo for acute postoperative pain

Dexketoprofen 20 mg or 25 mg compared with placebo for acute postoperative pain
Patient or population: adults with moderate or severe acute postoperative pain Settings: clinic or hospital Intervention: dexketoprofen 20 mg or 25 mg Comparison: placebo
Outcomes	Probable outcome with intervention	Probable outcome with placebo	RR, NNT, NNTp, or NNH (95% CI)	Number of studies, participants, or events	Quality of the evidence (GRADE)	Comments
Participants with ≥ 50% pain relief over 4‐6 hours	520 in 1000	270 in 1000	RR 2.0 (1.6 to 2.2) NNT 4.1 (3.3 to 5.2)	8 studies 1177 participants	High quality	Good quality studies, important outcome available, robust numbers
Median (mean) time to use of rescue medication	4.7 hours (5.2 hours)	1.8 hours (3.6 hours)	Not estimated	3 studies 281 participants (3 studies, 251 participants)	Very low quality	Small numbers of participants.
Participants using rescue medication over 6 hours	470 in 1000	690 in 1000	RR 0.66 (0.56 to 0.78) NNTp 4.7 (3.3 to 8.0)	5 studies 445 participants	High quality	Reasonable numbers of participants and high event rate.
Participants with ≥ 1 adverse event following a single dose	160 in 1000	100 in 1000	RR 1.4 (0.89 to 2.2) NNH not calculated	6 studies 536 participants	High quality	Good quality studies, important outcome available, robust numbers.
Participants with a serious adverse event following a single dose	No serious adverse events reported		Not estimated	9 studies 1271 participants	Very low quality	No events in single dose studies not designed to evaluate serious but rare adverse events.
CI: confidence interval; NNH: number needed to treat for an additional harmful outcome; NNT: number needed for one additional beneficial outcome; NNTp: number needed to treat to prevent an additional outcome: RR: risk ratio.
We used the following descriptors for levels of evidence (EPOC 2015). High: this research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different^a is low. Moderate: this research provides a good indication of the likely effect. The likelihood that the effect will be substantially different^a is moderate. Low: this research provides some indication of the likely effect. However, the likelihood that it will be substantially different^a is high. Very low: this research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different^a is very high. ^a Substantially different: a large enough difference that it might affect a decision.

Summary of findings 4. Dexketoprofen 20 mg or 25 mg compared with placebo for acute postoperative pain

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Comparison 1. Ketoprofen 12.5 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants with ≥ 50% pain relief over 6 hours Show forest plot	3	274	Risk Ratio (M‐H, Fixed, 95% CI)	4.21 [2.68, 6.63]

2 Participants using rescue medication over 6 hours Show forest plot	2	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.74, 0.90]

3 Participants with any adverse event Show forest plot	3	274	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.48, 3.64]

Comparison 1. Ketoprofen 12.5 mg versus placebo

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Comparison 2. Ketoprofen 25 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants with ≥ 50% pain relief over 6 hours Show forest plot	8	535	Risk Ratio (M‐H, Fixed, 95% CI)	4.88 [3.48, 6.85]

1.1 Dental surgery	6	452	Risk Ratio (M‐H, Fixed, 95% CI)	5.07 [3.50, 7.36]
1.2 Other surgery	2	83	Risk Ratio (M‐H, Fixed, 95% CI)	3.96 [1.77, 8.86]
2 Participants using rescue medication over 6 hours Show forest plot	6	402	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.52, 0.69]

3 Participants with any adverse event Show forest plot	7	490	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.68, 1.96]

Comparison 2. Ketoprofen 25 mg versus placebo

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Comparison 3. Ketoprofen 50 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants with ≥ 50% pain relief over 4‐6 hours Show forest plot	8	594	Risk Ratio (M‐H, Fixed, 95% CI)	2.49 [1.97, 3.14]

1.1 Dental surgery	3	190	Risk Ratio (M‐H, Fixed, 95% CI)	9.04 [4.23, 19.30]
1.2 Other surgery	5	404	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [1.40, 2.28]
2 Participants using rescue medication over 6‐8 hours Show forest plot	6	468	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.47, 0.66]

2.1 6 hours	4	263	Risk Ratio (M‐H, Fixed, 95% CI)	0.42 [0.33, 0.54]
2.2 8 hours	2	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.61, 0.98]
3 Participants with any adverse event Show forest plot	5	342	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [0.98, 2.75]

Comparison 3. Ketoprofen 50 mg versus placebo

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Comparison 4. Ketoprofen 80 mg or 100 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants with ≥ 50% pain relief Show forest plot	6	381	Risk Ratio (M‐H, Fixed, 95% CI)	4.29 [3.02, 6.08]

1.1 Dental surgery	4	255	Risk Ratio (M‐H, Fixed, 95% CI)	8.33 [4.67, 14.86]
1.2 Other surgery	2	126	Risk Ratio (M‐H, Fixed, 95% CI)	1.94 [1.26, 3.00]
2 Participants using rescue medication over 6‐8 hours Show forest plot	4	259	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.44, 0.67]

2.1 6 hours	3	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.38, 0.65]
2.2 8 hours	1	96	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.44, 0.89]
3 Participants with any adverse event Show forest plot	3	175	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.65, 2.16]

Comparison 4. Ketoprofen 80 mg or 100 mg versus placebo

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Comparison 5. Dexketoprofen 10 mg or 12.5 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants with ≥ 50% pain relief over 4‐6 hours Show forest plot	5	480	Risk Ratio (M‐H, Fixed, 95% CI)	2.43 [1.79, 3.28]

1.1 Dental surgery	4	373	Risk Ratio (M‐H, Fixed, 95% CI)	3.16 [2.08, 4.80]
1.2 Other surgery	1	107	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.00, 2.35]
2 Participants using rescue medication over 6‐8 hours Show forest plot	5	480	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.58, 0.81]

2.1 6 hours	4	373	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.61, 0.86]
2.2 8 hours	1	107	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.30, 0.82]
3 Participants with any adverse event Show forest plot	4	380	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.36, 1.35]

Comparison 5. Dexketoprofen 10 mg or 12.5 mg versus placebo

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Comparison 6. Dexketoprofen 20 mg or 25 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants with ≥ 50% pain relief over 4‐6 hours Show forest plot	8	1177	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [1.68, 2.28]

1.1 Dental surgery	5	444	Risk Ratio (M‐H, Fixed, 95% CI)	4.66 [3.12, 6.95]
1.2 Other surgery	3	733	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [1.26, 1.74]
2 Participants using rescue medication over 6‐8 hours Show forest plot	7	635	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.59, 0.77]

2.1 6 hours	5	445	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.56, 0.78]
2.2 8 hours	2	190	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.57, 0.89]
3 Participants with any adverse event Show forest plot	6	536	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.89, 2.23]

Comparison 6. Dexketoprofen 20 mg or 25 mg versus placebo

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