Single dose oral lornoxicam for acute postoperative pain in adults

Peter E Hall; Sheena Derry; R Andrew Moore; Henry J McQuay

doi:10.1002/14651858.CD007441.pub2

Dosis única oral de lornoxicam para el dolor posoperatorio agudo en pacientes adultos

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Referencias

References to studies included in this review

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estudios excluidos
otras referencias

Moller PL, Norholt SE. Analgesic efficacy of quick‐release versus standard lornoxicam for pain after third molar surgery: a randomized, double‐blind, placebo‐controlled, single‐dose trial. Clinical drug investigation 2008;28(12):757‐66. [PUBMED: 18991469]

Norholt SE, Sindet‐Pedersen S, Bugge C, Branebjerg PE, Ersboll BK, Bastian HL. A randomized, double‐blind, placebo‐controlled, dose‐response study of the analgesic effect of lornoxicam after surgical removal of mandibular third molars. Journal of clinical pharmacology 1995;35(6):606‐14. [PUBMED: 7665721]

Patel A, Skelly AM, Kohn H, Preiskel HW. Double‐blind placebo‐controlled comparison of the analgesic effects of single doses of lornoxicam and aspirin in patients with postoperative dental pain. British Dental Journal 1991;170(8):295‐9. [PUBMED: 2036277]

References to studies excluded from this review

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estudios incluidos
otras referencias

Cooper SA, Fielding AF, Lucyk D, Hersh EV, Quinn PD, Betts N, et al. Lornoxicam: Analgesic efficacy and safety of a new oxicam derivative. Advances in Therapy 1996;13(1):67‐77.

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Additional references

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estudios excluidos

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Collins SL, Edwards J, Moore RA, Smith LA, McQuay HJ. Seeking a simple measure of analgesia for mega‐trials: is a single global assessment good enough?. Pain 2001;91(1‐2):189‐94.

Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995;310(6977):452‐4.

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Lloyd R, Derry S, Moore RA, McQuay HJ. Intravenous or intramuscular parecoxib for acute postoperative pain in adults. Cochrane Database of Systematic Reviews. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD004771.pub4]

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Tramèr MR, Reynolds DJ, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta‐analysis: a case study. BMJ 1997;315(7109):635‐40.

Warrington SJ, Debbas NM, Farthing M, Horton M, Johnston A, Thillainayagam A, et al. Lornoxicam, indomethacin and placebo: comparison of effects on faecal blood loss and upper gastrointestinal endoscopic appearances in healthy men. Postgraduate Medical Journal 1990;66(778):622‐6. [PUBMED: 2217030]

Warrington SJ, Lewis Y, Dawnay A, Johnston A, Kovacs IB, Lamb E, et al. Renal and gastrointestinal tolerability of lornoxicam, and effects on haemostasis and hepatic microsomal oxidation. Postgraduate Medical Journal 1990;66 Suppl 4:S35‐40. [PUBMED: 2284219]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Moller 2008

Methods	RCT, DB, DD, placebo‐controlled parallel‐group study, single oral dose after onset of moderate‐severe pain, 24 hour study
Participants	Postoperative dental surgery ‐ third molar tooth extraction N = 200 M = 93, F = 107 Age 18‐40 years Mean age 25 years
Interventions	Lornoxicam 8 mg standard release, n = 80 Lornoxicam 8 mg quick release, n = 80 Placebo, n = 40
Outcomes	PI: 100 mm VAS PR: standard 5 point scale PGE: standard 5 point scale Number using rescue medication Time to use of rescue medication Adverse events: any, serious Withdrawals: all cause, adverse event
Notes	QS = 4 (R1, D2, W1)

Norholt 1995

Methods	RCT, DB, placebo and active controlled, parallel group study, single oral dose after moderate‐severe pain, 8 hour study
Participants	Postoperative dental surgery ‐ third molar tooth extraction N = 278 M = 160, F = 118 Age 17‐40 years Mean age 26 years
Interventions	Lornoxicam 4 mg, n = 43 Lornoxicam 8 mg, n = 45 Lornoxicam 16 mg, n = 48 Lornoxicam 32 mg, n = 48 Ketorolac 10 mg, n = 46 Placebo, n = 48
Outcomes	PI: non‐standard scale PR: standard 5 point scale PGE: standard 5 point scale Time to use of rescue medication Adverse events: any Withdrawals: all cause withdrawal, adverse event withdrawal
Notes	QS = 3 (R1, D1, W1)

Patel 1991

Methods	RCT, DB, placebo and active controlled, parallel group study, single oral dose after moderate‐severe pain, 8 hour study
Participants	Postoperative dental surgery ‐ third molar tooth extraction N = 150 M = 71, F = 79 Age >16 years Mean age 24 years
Interventions	Lornoxicam 2 mg, n = 30 Lornoxicam 4 mg, n = 30 Lornoxicam 8 mg, n = 30 Aspirin 650 mg, n = 30 Placebo, n = 30
Outcomes	PI: standard 4 point scale PR: standard 5 point scale PGE: standard 5 point scale Adverse events: any, serious Withdrawals: all cause, adverse event
Notes	QS = 3 (R1, D1, W1)

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Cooper 1996	Pre‐emptive pain relief

Data and analyses

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Comparison 1. Lornoxicam 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 6 hours Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 Lornoxicam versus placebo, Outcome 1 Participants with at least 50% pain relief over 6 hours.
1.1 Lornoxicam 4 mg	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	2.35 [1.33, 4.14]
1.2 Lornoxicam 8 mg	3	273	Risk Ratio (M‐H, Fixed, 95% CI)	4.69 [2.70, 8.12]
2 Participants with any adverse event Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1 Lornoxicam versus placebo, Outcome 2 Participants with any adverse event.
2.1 Lornoxicam 2 to 8 mg	2	320	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.92, 2.17]
2.2 Lornoxicam 8 mg	2	260	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.92, 2.21]

Figure 1

Forest plot of comparison: 3 Lornoxicam versus placebo, outcome: 3.1 Participants with at least 50% pain relief over 6 hours.

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Analysis 1.1

Comparison 1 Lornoxicam versus placebo, Outcome 1 Participants with at least 50% pain relief over 6 hours.

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Analysis 1.2

Comparison 1 Lornoxicam versus placebo, Outcome 2 Participants with any adverse event.

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Table 1. Summary of outcomes: analgesia and rescue medication

		Analgesia			Rescue medication
Study ID	Treatment	PI or PR	Number with 50% PR	PGE: v good or excellent	Median time to use (h)	% using
Moller 2008	(1) Lornoxicam 8 mg SR, n = 80 (2) Lornoxicam 8 mg QR, n = 80 (3) Placebo, n = 40	TOTPAR 6: (1) 8.1 (2) 11.3 (3) 1.8	(1) 27/80 (2) 41/80 (3) 0/40	No usable data	(1) 4.0 (2) 5.7 (3) 1.1	at 8 h: (1) 48/80 (2) 50/80 (3) 37/40
Norholt 1995	(1) Lornoxicam 4 mg, n = 43 (2) Lornoxicam 8 mg, n = 45 (3) Lornoxicam 16 mg, n = 48 (4) Lornoxicam 32 mg, n = 48 (5) Ketorolac 10 mg, n = 46 (6) Placebo, n = 48	TOTPAR 6: (1) 9.6 (2) 13.7 (3) 15.0 (4) 17.7 (6) 3.7	(1) 18/43 (2) 29/45 (3) 34/48 (4) 42/48 (6) 4/48	(1) 12/43 (2) 23/45 (3) 27/48 (4) 32/48 (5) 25/46 (6) 4/48	Mean: (1) 3.1 (2) 4.1 (3) 4.9 (4) 5.1 (6) 1.7	No data
Patel 1991	(1) Lornoxicam 2 mg, n = 30 (2) Lornoxicam 4 mg, n = 30 (3) Lornoxicam 8 mg, n = 30 (4) Aspirin 650 mg, n = 30 (6) Placebo, n = 30	TOTPAR 6: (1) 8.43 (2) 8.99 (3) 11.12 (5) 7.38	(1) 11/30 (2) 11/30 (3) 15/30 (5) 9/30	No usable data	No data	No data
QR ‐ quick release; SR ‐ slow release

Table 1. Summary of outcomes: analgesia and rescue medication

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Table 2. Summary of outcomes: adverse events and withdrawals

		Adverse events		Withdrawals
Study ID	Treatment	Any	Serious	Adverse event	Other
Moller 2008	(1) Lornoxicam 8 mg SR, n = 80 (2) Lornoxicam 8 mg QR, n = 80 (3) Placebo, n = 40	at 7 days: (1) 39/80 (2) 43/80 (3) 14/40	None	None	None
Norholt 1995	(1) Lornoxicam 4 mg, n = 43 (2) Lornoxicam 8 mg, n = 45 (3) Lornoxicam 16 mg, n = 48 (4) Lornoxicam 32 mg, n = 48 (5) Ketorolac 10 mg, n = 46 (6) Placebo, n = 48	No usable data	None reported	None	None
Patel 1991	(1) Lornoxicam 2 mg, n = 30 (2) Lornoxicam 4 mg, n = 30 (3) Lornoxicam 8 mg, n = 30 (4) Aspirin 650 mg, n = 30 (6) Placebo, n = 30	at 8 h: (1) 3/30 (2) 1/30 (3) 2/30 (4) 2/30 (5) 2/30	None	None	None
QR ‐ quick release; SR ‐ slow release

Table 2. Summary of outcomes: adverse events and withdrawals

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Comparison 1. Lornoxicam 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 6 hours Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Lornoxicam 4 mg	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	2.35 [1.33, 4.14]
1.2 Lornoxicam 8 mg	3	273	Risk Ratio (M‐H, Fixed, 95% CI)	4.69 [2.70, 8.12]
2 Participants with any adverse event Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Lornoxicam 2 to 8 mg	2	320	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.92, 2.17]
2.2 Lornoxicam 8 mg	2	260	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.92, 2.21]

Comparison 1. Lornoxicam versus placebo

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Referencias

References to studies included in this review

Moller 2008 {published data only}

Norholt 1995 {published data only}

Patel 1991 {published data only}

References to studies excluded from this review

Cooper 1996 {published data only}

Additional references

Barden 2004

Barden 2006

Berg 1999

Berry 1992

Clarke 2009

Collins 1997

Collins 2001

Cook 1995

Cooper 1991

Derry 2008

Derry C 2009a

Derry C 2009b

Derry P 2009

Dittrich 1990

Erdogan 2008

Fitzgerald 2001

Gaskell 2009

Hawkey 1999

Hitzenberger 1990

Jadad 1996a

Jadad 1996b

L'Abbé 1987

Lloyd 2009

McQuay 2005

Moore 1996

Moore 1997a

Moore 1997b

Moore 1998

Moore 2003

Moore 2005

Moore 2006

Morris 1995

Papadima 2007

Sener 2008

Toms 2008

Tramèr 1997

Warrington 1990a

Warrington 1990b

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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