Single dose oral celecoxib for acute postoperative pain in adults

Sheena Derry; R Andrew Moore

doi:10.1002/14651858.CD004233.pub4

Single dose oral celecoxib for acute postoperative pain in adults

Contraer todo Desplegar todo

Referencias

References to studies included in this review

Ir a:

estudios excluidos
estudios a la espera de valoración
otras referencias

Cheung R, Krishnaswami S, Kowalski K. Analgesic efficacy of celecoxib in postoperative oral surgery pain: a single‐dose, two‐center, randomized, double‐blind, active‐ and placebo‐controlled study. Clinical Therapeutics 2007;29 Suppl:2498‐510.

Doyle G, Jayawardena S, Ashraf E, Cooper SA. Efficacy and tolerability of nonprescription ibuprofen versus celecoxib for dental pain. Journal of Clinical Pharmacology 2002;42(8):912‐9.

Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. The Journal of Pain 2008;9(1):20‐7.

Gimbel JS, Brugger A, Zhao W, Verburg KM, Geis GS. Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Clinical Therapeutics 2001;23(2):228‐41.

A phase 2, randomized, double‐blind, single‐dose, parallel‐group, active‐ and placebo‐controlled study of indomethacin test capsules for the treatment of pain after surgical removal of impacted third molars. http://www.clinicaltrials.gov/ 2013 (Accessed 31 May 2013). [CTG: NCT00964431]

Kellstein D, Ott D, Jayawardene S, Fricke J. Analgesic efficacy of a single dose of lumiracoxib compared with rofecoxib, celecoxib and placebo in the treatment of post‐operative dental pain. International Journal of Clinical Practice 2004;58(3):244‐50.

Malmstrom K, Daniels S, Kotey P, Seidenburg BC, Desjardins PJ. Comparison of rofecoxib and celecoxib, two cyclooxygenase‐2 inhibitors, in postoperative dental pain: a randomised, placebo‐ and active‐comparator‐controlled clinical trial. Clinical Therapeutics 1999;21(10):1653‐63.

Malmstrom K, Fricke JR, Kotey P, Kress B, Morrison B. A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single‐center, randomized, double‐blind, placebo‐ and active‐comparator‐controlled, parallel‐group, single‐dose study using the dental impaction pain model. Clinical Therapeutics 2002;24(10):1549‐60.

Manvelian G, Daniels S, Gibofsky A. A phase 2 study evaluating the efficacy and safety of a novel, proprietary, nano‐formulated, lower dose oral diclofenac. Pain Medicine 2012;13(11):1491‐8. [DOI: 10.1111/j.1526‐4637.2012.01479.x]

Moberly JB, Xu J, Desjardins PJ, Daniels SE, Bandy DP, Lawson JE, et al. A randomized, double‐blind, celecoxib‐ and placebo‐controlled study of the effectiveness of CS‐706 in acute postoperative dental pain. Clinical Therapeutics 2007;29(3):399‐412.

References to studies excluded from this review

Ir a:

estudios incluidos
estudios a la espera de valoración
otras referencias

Saito K, Kaneko A, Machii K, Ohta H, Ohkura M, Suzuki M. Efficacy and safety of additional 200‐mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double‐blind, placebo‐controlled, phase II study in Japan. Clinical Therapeutics 2012;34(2):314‐28. [DOI: 10.1016/j.clinthera.2012.01.004]

Salo DF, Lavery R, Varma V, Goldberg J, Shapiro T, Kenwood A. A randomized, clinical trial comparing oral celecoxib 200 mg, celecoxib 400 mg, and ibuprofen 600 mg for acute pain. Academic Emergency Medicine 2003;10:22‐30.

White PF, Sacan O, Tufanogullari B, Eng M, Nuangchamnong N, Ogunnaike B. Effect of short‐term postoperative celecoxib administration on patient outcome after outpatient laparoscopic surgery. Canadian Journal of Anaesthesia 2007;54(5):342‐8.

References to studies awaiting assessment

Ir a:

estudios incluidos
estudios excluidos
otras referencias

An etodolac‐ and placebo‐controlled, multicenter, double‐blind, group comparison study to verify the efficacy of YM177 (celecoxib) in postoperative pain patients. [CTG: NCT01118572]

A randomized, double‐blind, placebo‐ and active‐controlled, parallel‐group analgesic efficacy trial of oral ARRY‐371797 in subjects undergoing third molar extraction. [CTG: NCT00663767]

Shirota T, Ohno K‐S, Michii K‐I, Kamijo R, Nagumo M, Sato H, et al. A study of the dose‐response of YM177 for treatment of postsurgical dental pain. Oral Therapeutics and Pharmacology 2001;20(3):154‐72.

Google Scholar

Additional references

Ir a:

estudios incluidos
estudios excluidos
estudios a la espera de valoración

Barden J, Edwards JE, McQuay HJ, Andrew Moore R. Pain and analgesic response after third molar extraction and other postsurgical pain. Pain 2004;107(1‐2):86‐90. [DOI: 10.1016/j.pain.2003.09.021]

Clarke R, Derry S, Moore RA. Single dose oral etoricoxib for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/14651858.CD004309.pub3]

Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres?. Pain 1997;72:95‐7.

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;91:189‐94.

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

Cooper SA. Single‐dose analgesic studies: the upside and downside of assay sensitivity. In: Max MB, Portenoy RK, Laska EM editor(s). The Design of Analgesic ClinicalTrials. Advances in Pain Research and Therapy. Vol. 18, New York: Raven Press, 1991:117‐24.

Google Scholar

Derry S, Wiffen PJ, Moore RA. Relative efficacy of oral analgesics after third molar extraction – a 2011 update. British Dental Journal 2011;211(9):419‐20. [DOI: 10.1038/sj.bdj.2011.905]

Derry S, Moore RA. Single dose oral aspirin for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/14651858.CD002067.pub2]

Derry C, Derry S, Moore RA, McQuay HJ. Single dose oral naproxen and naproxen sodium for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD004234.pub2]

Derry C, Derry S, Moore RA, McQuay HJ. Single dose oral ibuprofen for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD001548.pub2]

Derry P, Derry S, Moore RA, McQuay HJ. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD004768.pub2]

Google Scholar

Edwards JE, Oldman AD, Smith LA, Carroll D, Wiffen PJ, McQuay HJ, et al. Oral aspirin in postoperative pain: a quantitative systematic review. Pain 1999;81:289‐97.

Edwards JE, McQuay HJ, Moore RA, Collins SL. Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. Journal of Pain and Symptom Management 1999;18(6):427‐37.

Garner S, Fidan D, Frankish R, Judd M, Towheed T, Wells G, et al. Rofecoxib for the treatment of rheumatoid arthritis. Cochrane Database of Systematic Reviews 2002, Issue 2. [DOI: 10.1002/14651858.CD003685.pub2]

Google Scholar

Grahame‐Smith DG, Aronson JK. Oxford Textbook of Clinical Pharmacology and Drug Therapy. 3rd Edition. Oxford: Oxford University Press, 2002.

Hawkey CJ. Cox‐2 inhibitors. Lancet 1999;353(9149):307‐14.

Hawkey, CJ. Gastrointestinal safety of COX‐2 specific inhibitors. Gastroenterology Clinics of North America 2001;30(4):921‐36.

Altman DG, Antes G, Gøtzsche P, Higgins JPT, Jüni P, Lewis S, et al. Assessing risk of bias in included studies. In: Higgins JPT, Altman DG, Sterne JAC editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. www.cochrane‐handbook.org. The Cochrane Collaboration, 2011.

Google Scholar

Jadad A, Carroll D, Moore RA, McQuay HJ. Developing a database of published reports of randomised clinical trials in pain research. Pain 1996;66:239‐46.

Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17:1‐12.

L'Abbé KA, Detsky AS, O'Rourke K. Meta‐analysis in clinical research. Annals of Internal Medicine 1987;107:224‐33.

McQuay HJ, Moore RA. Placebo. Postgraduate Medical Journal 2005;81:155‐60.

Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta‐analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta‐analyses. Lancet 1999;27(354):1896‐900.

Google Scholar

Moore A, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics. Pain 1996;66(2‐3):229‐37.

Moore A, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: verification from independent data. Pain 1997;69(1‐2):127‐30.

Moore A, Moore O, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: use of pain intensity and visual analogue scales. Pain 1997;69(3):311‐5.

Moore RA, Gavaghan D, Tramer M, Collins SL, McQuay HJ. Size is everything ‐ large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain 1998;78(3):209‐16.

Moore RA, Edwards J, Barden J, McQuay HJ. Bandolier's Little Book of Pain. Oxford: Oxford University Press, 2003.

Moore RA, Edwards JE, McQuay HJ. Acute pain: individual patient meta‐analysis shows the impact of different ways of analysing and presenting results. Pain 2005;116(3):322‐31.

Moore RA, Derry S, Makinson GT, McQuay HJ. Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta‐analysis of information from company clinical trial reports. Arthritis Research and Therapy 2005;7(3):R644‐65.

Moore A, McQuay H. Bandolier's Little Book of Making Sense of the Medical Evidence. Oxford: Oxford University Press, 2006.

Moore RA, Barden J, Derry S, McQuay HJ. Managing potential publication bias. In: McQuay HJ, Kalso E, Moore RA editor(s). Systematic Reviews in Pain Research: Methodology Refined. Seattle: IASP Press, 2008:15‐24. [ISBN: 978‐0‐931092‐69‐5]

Google Scholar

Moore RA, Derry S, McQuay HJ, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database of Systematic Reviews 2011, Issue 9. [DOI: 10.1002/14651858.CD008659.pub2]

Moore RA, Straube S, Paine J, Derry S, McQuay HJ. Minimum efficacy criteria for comparisons between treatments using individual patient meta‐analysis of acute pain trials: examples of etoricoxib, paracetamol, ibuprofen, and ibuprofen/paracetamol combinations after third molar extraction. Pain 2011;152(5):982‐9. [DOI: doi:10.1016/j.pain.2010.11.030]

Morris JA, Gardner MJ. Calculating confidence intervals for relative risk, odds ratio and standardised ratios and rates. In: Gardner MJ, Altman DG editor(s). Statistics with Confidence. London: British Medical Journal, 1995:50‐63.

Google Scholar

Nüesch E, Trelle S, Reichenbach S, Rutjes AW, Tschannen B, Altman DG, et al. Small study effects in meta‐analyses of osteoarthritis trials: meta‐epidemiological study. BMJ 2010;341:c3515. [DOI: 10.1136/bmj.c3515]

Prescription Cost Analysis England. The NHS Information Centre for Health and Social Care2010. [ISBN: 978‐1‐84636‐542‐3]

Patrono C, Baigent C. Low‐dose aspirin, coxibs, and other NSAIDS: a clinical mosaic emerges. Molecular Interventions 2009;9(1):31‐9.

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.

Roy YM, Derry S, Moore RA. Single dose oral lumiracoxib for postoperative pain in adults. Cochrane Database of Systematic Reviews 2010, Issue 7. [DOI: 10.1002/14651858.CD006865.pub2]

Ruff CT, Morrow DA, Jarolim P, Ren F, Contant CF, Kaur A, et al. Evaluation of NT‐proBNP and high sensitivity C‐reactive protein for predicting cardiovascular risk in patients with arthritis taking longterm nonsteroidal antiinflammatory drugs. Journal of Rheumatology 2011;38(6):1071‐8. [DOI: 10.3899/jrheum.100880]

Straube S, Derry S, McQuay HJ, Moore RA. Effect of preoperative Cox‐II‐selective NSAIDs (coxibs) on postoperative outcomes: a systematic review of randomized studies. Acta Anaesthesiologica Scandinavica 2005;49(5):601‐13.

Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol (acetaminophen) for postoperative pain in adults. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD004602]

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

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

estudios excluidos
estudios a la espera de clasificación

Cheung 2007

Methods	RCT, DB single oral dose, 3 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then hourly up to 12 h, and at 16 and 24 h
Participants	Impacted third molar extraction Mean age 22 years N = 171 M = 77, F = 94
Interventions	Celecoxib 400 mg, n = 57 Ibuprofen 400 mg, n = 57 Placebo, n = 57
Outcomes	PI: std 4‐point scale PR: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event
Notes	Oxford Quality Score: R2, DB2, W1 Participants asked to refrain from rescue medication for 1 h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer‐generated randomization schedule, prepared before the start of the study"
Allocation concealment (selection bias)	Low risk	Medication supplied in patient‐specific carton. Identity of assignment contained in concealed section of label, which was removed at dispensing, and attached to patient case report form
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind method. Placebo capsules or tablets identical in number and appearance to active treatments
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (57 participants)

Doyle 2002

Methods	RCT, DB single oral and multiple oral dose, 3 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then hourly up to 12 h
Participants	Impacted third molar extraction Mean age 22 years N = 174 M = 75, F = 99
Interventions	Celecoxib 200 mg, n = 74 Ibuprofen liquigel 400 mg, n = 74 Placebo, n = 26
Outcomes	PI: 4‐point scale PR: 5‐point scale PGE: std 5‐point scale (patients reporting "very good" or "excellent") Time to use of rescue medication Number of participants using rescue medication Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event
Notes	Oxford Quality Score: R2, DB2, W1 Participants asked to refrain from rescue medication for 1 h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer‐generated allocation schedule"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐dummy method. "The appearance, presentation and labelling of the placebo formulations were identical to those of the corresponding active drugs"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (74 active, 26 placebo participants)

Fricke 2008

Methods	RCT, DB, double‐dummy, single oral dose, 3 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then hourly up to 12 h, and at 24 h
Participants	Impacted third molar extraction Mean age 23 years N = 364 M = 133, F = 231
Interventions	Celecoxib 400 mg, n = 156 Lumiracoxib 400 mg, n = 156 Placebo, n = 52
Outcomes	PI: std 4‐point scale PR: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event
Notes	Oxford Quality Score: R2, DB1, W1 Participants permitted to use rescue medication at any time
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Low risk	Remote, automated allocation to randomisation numbers
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (156 active, 52 placebo participants)

Gimbel 2001

Methods	RCT, DB single oral and multiple oral dose, 3 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then hourly up to 8 h. Multiple‐dose phase continued over 3 days
Participants	Orthopaedic surgery (uncomplicated) Mean age 46 years N = 418 M = 165, F = 253
Interventions	Celecoxib 200 mg, n = 141 Hydrocodone 10 mg + acetaminophen 1000 mg, n = 136 Placebo, n = 141
Outcomes	PI: std 4‐point scale PR: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event
Notes	Oxford Quality Score: R1, DB1, W1 Participants permitted to use rescue medication at any time
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (136 to 141 participants)

IND2‐08‐03

Methods	Randomised, double‐blind, single‐dose, parallel‐group, duration 8 h Medication given when pain ≥ moderate
Participants	Surgical removal of ≥ 2 impacted third molars M and F, age 18 to 50 years N = 203
Interventions	Celecoxib 400 mg, n = 51 Indomethacin 20 mg, n = 50 Indomethacin 40 mg, n = 51 Placebo, n = 51
Outcomes	PI: std 4‐point scale PR: std 5‐point scale Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event
Notes	Clinical trial summary Oxford Quality Score: R1, DB1, W1
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear how data from withdrawals were handled
Size	Unclear risk	Small treatment group size (50 to 51 participants)

Kellstein 2004

Methods	RCT, DB, double‐dummy, single oral dose, 4 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, 90 mins then hourly up to 12 h, and at 24 h
Participants	Impacted third molar extraction Mean age 22 years N = 355 M = 112, F = 243
Interventions	Celecoxib 200 mg, n = 101 Lumiracoxib 400 mg, n = 101 Rofecoxib 50 mg, n = 102 Placebo, n = 51
Outcomes	PI: std 4‐point scale PR: std 5‐point scale PGE: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication
Notes	Oxford Quality Score: R1, DB2, W1 Participants asked to refrain from rescue medication for 1 h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐dummy method. Placebo capsules and tablets matching corresponding active treatments
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (100 to 101 active, 51 placebo participants)

Malmstrom 1999

Methods	RCT, DB single oral dose and multiple oral dose, 4 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, and 90 mins, then at 2, 3, 4, 5, 6, 7, 8 h
Participants	Impacted third molar extraction Mean age 23 years N = 272 M = 100, F = 172
Interventions	Celecoxib 200 mg, n = 91 Rofecoxib 50 mg, n = 90 Ibuprofen 400 mg, n = 46 Placebo, n = 45
Outcomes	PI: std 4‐point scale PR: std 5‐point scale PGE: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication
Notes	Oxford Quality Score: R2, DB2, W1 Participants asked to refrain from rescue medication for 1.5 h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer‐generated allocation schedule"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐dummy method, using marketed tablet or capsule formulations or matching placebos
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (90, 91 coxib, 45, 46 ibuprofen, and placebo participants)

Malmstrom 2002

Methods	RCT, DB single oral dose, 5 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, and 90 mins, then at 2, 3, 4, 5, 6, 7, 8, and 12 h
Participants	Impacted third molar extraction Mean age 22 years N = 482 M = 124, F = 358
Interventions	Celecoxib 400 mg, n = 151 Celecoxib 200 mg, n = 90 Rofecoxib 50 mg, n = 150 Ibuprofen 400 mg, n = 45 Placebo, n = 45
Outcomes	PI: std 4‐point scale PR: std 5‐point scale PGE: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication
Notes	Oxford Quality Score: R2, DB2, W1 Participants asked to refrain from rescue medication for 1.5 h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer‐generated allocation schedule"
Allocation concealment (selection bias)	Low risk	Participants allocated to next randomisation number (lowest for moderate pain, highest for severe pain)
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐dummy method. Each active treatment had matching placebo tablets or capsules
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (90 to 151 coxib, 45 to 50 ibuprofen, and placebo participants)

Manvelian 2012

Methods	Randomised, double‐blind, single‐dose, parallel‐group, duration 12 h Medication given when pain ≥ moderate Pain assessed at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12 h
Participants	Surgical removal of ≥ 2 impacted third molars M and F, age 18 to 50 years N = 202
Interventions	Celecoxib 400 mg, n = 51 Diclofenac, nano‐formulated 18 mg, n = 49 Diclofenac, nano‐formulated 35 mg, n = 51 Placebo, n = 51
Outcomes	PI: std 4‐point scale PR: std 5‐point scale Time to use of rescue medication Number of participants reporting any adverse event and serious adverse events Number of participants withdrawing due to adverse event
Notes	Oxford Quality Score: R1, D1, W0 Participants asked to refrain from rescue medication for 1h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear how data from withdrawals were handled
Size	Unclear risk	Small treatment group size (49 to 51 participants)

Moberly 2007

Methods	RCT, DB single oral dose, 6 parallel groups Medication administered when baseline pain reached a moderate to severe intensity Pain assessed at 0, 15, 30, 45, 60, and 90 mins, then at 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 h
Participants	Impacted third molar extraction Mean age 22 years N = 304 M = 111, F = 193
Interventions	Celecoxib 400 mg, n = 51 Placebo, n = 52 CS‐706 also tested at 10, 50, 100, 200 mg
Outcomes	PI: std 4‐point scale PR: std 5‐point scale PGE: std 5‐point scale Time to use of rescue medication Number of participants using rescue medication
Notes	Oxford Quality Score: R1, DB2, W1 Participants asked to refrain from rescue medication for 1.5 h
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Low risk	Investigator, all study staff and related personnel were unaware of treatment assignment
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐dummy method. Matching tablets for CS‐706 and corresponding placebo. Celecoxib and corresponding placebo capsules differed in markings, so participant blindfolded and treatment administered by a third party.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Participants accounted for; analysis appropriate for relevant time interval
Size	Unclear risk	Small treatment group size (50 to 51 participants)

RCT ‐ randomised controlled trial; R ‐ randomisation; DB ‐ double blind; W ‐ withdrawals; PI ‐ pain intensity; PR ‐ pain relief; PGE ‐ patient global evaluation; std ‐ standard

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos
estudios a la espera de clasificación

Study	Reason for exclusion
Saito 2012	No single‐dose data
Salo 2003	No placebo group; included participants with musculoskeletal injuries, not postoperative pain
White 2007	Not established moderate to severe pain

Characteristics of studies awaiting assessment [ordered by study ID]

Ir a:

estudios incluidos
estudios excluidos

177‐CL‐102

Methods	Randomised, double‐blind, parallel‐group, duration 2 days Medication given when pain ≥ moderate
Participants	Postoperative pain M and F, age ≥ 20 years N = 616
Interventions	Celecoxib Etodolac Placebo Doses not given
Outcomes	Patient impression Pain intensity, pain intensity difference Discontinuation due to lack of efficacy Adverse events
Notes	May not have single‐dose data Primary completion date November 2010

ARRY‐797‐221

Methods
Participants
Interventions
Outcomes
Notes	Mentioned as "recently completed postoperative pain study" in ARRY‐797‐22

ARRY‐797‐222

Methods	Randomised, double‐blind, single‐dose, parallel‐group, duration 6 h (to second dose) Medication given when pain ≥ moderate
Participants	Surgical removal of ≥ 3 third molars (1 mandibular and impacted) M and F, age 18 to 50 years N = 250
Interventions	Celecoxib 400 mg ARRY‐31797 200 mg ARRY‐31797 400 mg ARRY‐31797 600 mg Placebo
Outcomes	TOTPAR (dose 1) Use of rescue medication Adverse events
Notes	Primary completion June 2008

Shirota 2001

Methods
Participants
Interventions
Outcomes
Notes	Awaiting translation (Japanese)

Data and analyses

Open in table viewer

Comparison 1. Celecoxib 200 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 At least 50% pain relief over 4‐6 hours Show forest plot	4	705	Risk Ratio (M‐H, Fixed, 95% CI)	3.49 [2.40, 5.06]
Open in figure viewer Analysis 1.1 Comparison 1 Celecoxib 200 mg versus placebo, Outcome 1 At least 50% pain relief over 4‐6 hours.
1.1 Dental pain	3	423	Risk Ratio (M‐H, Fixed, 95% CI)	15.86 [5.14, 48.99]
1.2 Postsurgical pain	1	282	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.26, 2.68]
2 Use of rescue medication over 24 hours Show forest plot	2	271	Risk Ratio (IV, Fixed, 95% CI)	0.78 [0.70, 0.86]
Open in figure viewer Analysis 1.2 Comparison 1 Celecoxib 200 mg versus placebo, Outcome 2 Use of rescue medication over 24 hours.
3 Any adverse event Show forest plot	4	669	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.63, 1.29]
Open in figure viewer Analysis 1.3 Comparison 1 Celecoxib 200 mg versus placebo, Outcome 3 Any adverse event.
3.1 Dental	3	387	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.63, 1.49]
3.2 Orthopaedic	1	282	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.43, 1.48]

Open in table viewer

Comparison 2. Celecoxib 400 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 At least 50% pain relief over 4‐6 hours, dental pain Show forest plot	5	722	Risk Ratio (M‐H, Fixed, 95% CI)	10.26 [5.70, 18.47]
Open in figure viewer Analysis 2.1 Comparison 2 Celecoxib 400 mg versus placebo, Outcome 1 At least 50% pain relief over 4‐6 hours, dental pain.
2 Use of rescue medication over 24 hours Show forest plot	3	518	Risk Ratio (IV, Fixed, 95% CI)	0.68 [0.62, 0.74]
Open in figure viewer Analysis 2.2 Comparison 2 Celecoxib 400 mg versus placebo, Outcome 2 Use of rescue medication over 24 hours.
3 Any adverse event Show forest plot	6	725	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.84, 1.17]
Open in figure viewer Analysis 2.3 Comparison 2 Celecoxib 400 mg versus placebo, Outcome 3 Any adverse event.

Figure 1

Flow diagram.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 3

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 4

Forest plot of comparison: 1 Celecoxib 200 mg versus placebo, outcome: 1.1 At least 50% pain relief over 4‐6 hours.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 5

L'Abbé plot of celecoxib 200 mg versus placebo for at least 50% pain relief. Size of circle is proportional to size of study (inset scale). Cream circles ‐ dental studies; pink circle ‐ orthopaedic study.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 6

Forest plot of comparison: 2 Celecoxib 400 mg versus placebo, outcome: 2.1 At least 50% pain relief over 4‐6 hours dental pain.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 7

L'Abbé plot of celecoxib 400 mg versus placebo for at least 50% pain relief. Size of circle is proportional to size of study (inset scale). Cream circles ‐ dental studies

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.1

Comparison 1 Celecoxib 200 mg versus placebo, Outcome 1 At least 50% pain relief over 4‐6 hours.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.2

Comparison 1 Celecoxib 200 mg versus placebo, Outcome 2 Use of rescue medication over 24 hours.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.3

Comparison 1 Celecoxib 200 mg versus placebo, Outcome 3 Any adverse event.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.1

Comparison 2 Celecoxib 400 mg versus placebo, Outcome 1 At least 50% pain relief over 4‐6 hours, dental pain.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.2

Comparison 2 Celecoxib 400 mg versus placebo, Outcome 2 Use of rescue medication over 24 hours.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.3

Comparison 2 Celecoxib 400 mg versus placebo, Outcome 3 Any adverse event.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1. Celecoxib 200 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 At least 50% pain relief over 4‐6 hours Show forest plot	4	705	Risk Ratio (M‐H, Fixed, 95% CI)	3.49 [2.40, 5.06]

1.1 Dental pain	3	423	Risk Ratio (M‐H, Fixed, 95% CI)	15.86 [5.14, 48.99]
1.2 Postsurgical pain	1	282	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.26, 2.68]
2 Use of rescue medication over 24 hours Show forest plot	2	271	Risk Ratio (IV, Fixed, 95% CI)	0.78 [0.70, 0.86]

3 Any adverse event Show forest plot	4	669	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.63, 1.29]

3.1 Dental	3	387	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.63, 1.49]
3.2 Orthopaedic	1	282	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.43, 1.48]

Comparison 1. Celecoxib 200 mg versus placebo

Ir a la tabla de la revisión

Comparison 2. Celecoxib 400 mg versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 At least 50% pain relief over 4‐6 hours, dental pain Show forest plot	5	722	Risk Ratio (M‐H, Fixed, 95% CI)	10.26 [5.70, 18.47]

2 Use of rescue medication over 24 hours Show forest plot	3	518	Risk Ratio (IV, Fixed, 95% CI)	0.68 [0.62, 0.74]

3 Any adverse event Show forest plot	6	725	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.84, 1.17]

Comparison 2. Celecoxib 400 mg versus placebo

Ir a la tabla de la revisión

	Idioma de la Revisión Cochrane Escoja su idioma de preferencia para las revisiones Cochrane y otros contenidos. Las secciones sin una traducción aparecerán en inglés.

	Idioma de la web Escoja su idioma de preferencia para la web de la Biblioteca Cochrane.

Idioma de la Revisión Cochrane

Idioma de la web

Referencias

References to studies included in this review

Cheung 2007 {published data only}

Doyle 2002 {published data only}

Fricke 2008 {published data only}

Gimbel 2001 {published data only}

IND2‐08‐03 {unpublished data only}

Kellstein 2004 {published data only}

Malmstrom 1999 {published data only}

Malmstrom 2002 {published data only}

Manvelian 2012 {published data only}

Moberly 2007 {published data only}

References to studies excluded from this review

Saito 2012 {published data only}

Salo 2003 {published data only}

White 2007 {published data only}

References to studies awaiting assessment

177‐CL‐102 {unpublished data only}

ARRY‐797‐221 {unpublished data only}

ARRY‐797‐222 {unpublished data only}

Shirota 2001 {published data only}

Additional references

Barden 2004

Clarke 2012

Collins 1997

Collins 2001

Cook 1995

Cooper 1991

Derry 2011

Derry 2012

Derry C 2009a

Derry C 2009b

Derry P 2009

Edwards 1999a

Edwards 1999b

Garner 2002

Grahame‐Smith 2002

Hawkey 1999

Hawkey 2001

Higgins 2011

Jadad 1996a

Jadad 1996b

L'Abbé 1987

McQuay 2005

Moher 1999

Moore 1996

Moore 1997a

Moore 1997b

Moore 1998

Moore 2003

Moore 2005a

Moore 2005b

Moore 2006

Moore 2008

Moore 2011a

Moore 2011b

Morris 1995

Nuesch 2010

PACT 2010

Patrono 2009

RevMan 2012 [Computer program]

Roy 2010

Ruff 2011

Straube 2005

Toms 2008

Tramèr 1997

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of studies awaiting assessment [ordered by study ID]

Data and analyses

Copiar o descargar referencia

Idioma de la Revisión Cochrane

Idioma de la web

Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

Otras opciones de acceso