Evidence Table 12

Quality assessment of active-control and placebo-controlled trials for prevention of postoperative nausea and vomiting

Internal Validity
Author
Year
Randomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Reporting of attrition, crossovers, adherence, and contaminationLoss to follow-up:
differential/ high
Intention-to-treat (ITT) analysisPost-randomization exclusionsQuality RatingFunding
Adults: active controlled trials
Dolasetron
Burmeister 2003Unclear; done by using an MS Excel macroNRYesYesYesYesYesNo, No, No, NoNRNRNRFairAventis
Ondansetron
Doe
1998
NRNRNRYesNRYesYesNo, No, No, NoNRUnclearNoFair
Fortney
1998
NRNRYesYesNRYesYesYes, No, No, NoNo, NoYes for satisfaction; No for primary outcome (complete response)NoFairGlaxo Wellcome
Gan
2004
YesYesYes, but analysis excluded 2 patients (2.6%) that did not complete the studyYesYesYesYesYes, No, No, NoNoneNo, excluded 2 patients (2.6%)NoFairNR
Jokela
2002
NRNo, sealed envelope techniqueUnclear, excluded 21 patients (10.5%)YesNRYesYesYes, No, No, NoNoneNo, excluded 21 patients (10.5%) who didn’t complete due to reoperation (n=6) and unspecified protocol violations (n=15)NoFairNR
Khalil
1999
YesYesYesYesYesYesYesNo, No, No, NoNRYesNoFairNR
Purhonen
2006 (B)
NR
YesYesYesYesYesYesYesYes, Yes, Yes, YesNoneNRNoFairNR
Reihner
1999
NRYesNo, intraoperative blood loss significantly lower in ond. group; also, only reported baseline characteristics for 95.8%YesNRYesYesYes, No, No, NoNoneNo, excluded 9 pts (4.2%) due to protocol violationsNoFairNR
Sandhu
1999
NRNRYesYesYesYesYesNo, No, No, NoNRUnclearNoFairNR
Steinbrook
1996
YesYesUnclear, analysis excluded 15 pts (7.5%) that were converted to open surgeryYesYesYesYesYes, No, No, NoNoneNo, excluded 15 pts (7.5%)NoFairNR
Granisetron
Adults: placebo- controlled trials
Dolasetron
Diemunsch
1997
NRNRYesYesNRYesYesNo, No, No, NoNRUnclear, data NRNoFairHoechst Marion Roussel
Diemunsch,
1998
NRNRYesYesYesYesYesYes, No, No, NoNRNo. excluded 4 patients from efficacy analysisNoFairResearch grant from Hoechst Marion Roussel, Strasbourg, France
Warriner
1997
NRNRYesYesNRYesYesYes, No, No, NoNoneNo, but only excluded 1 patient (0.3%) that didn’t undergo surgeryNoFairNR; 3 members of study group affiliated with Hoechst Marion Roussel Canada Research Inc.
Granisetron
Ondansetron
Cherian
2001
YesYesNo, women in ondansetron group “slightly heavier” (significance NR; data NR)YesNRYesYesNo, No, No, NoNRYesNoFairNot funded by the pharmaceutical industry
Lekprasert
1996
NRNRNo, fewer pts taking ondansetron received intraoperative opioids and more pts taking ondansetron received gastric content suctionYesNRYesYesNo, No, No, NoNRYesNoFairNR
Scuderi
1999
YesNRYesYesNRYesYesNo, No, No, NoNRYesNoFairNR
Sun
1997
NRYesNo, fewer pts in the group that received ondansetron first had histories of PONVYesYesYesYesNo, No, No, NoNRYesNoFairNR
Tang
1998
YesYesYes, but only gave information about 95.1%YesYesYesYesYes, No, No, NoNoneNo, excluded 8 pts (4.8%) with protocol violationsNoFairGlaxo Wellcome
Thagaard
2003
YesNRNo: placebo patients were older and more of them were undergoing fundoplication; more ondansetron patients had histories of travel sickness and more were undergoing cholecystectomyYesNRYesYesYes, No, No, NoUnclear, NoExcluded 6 pts (5.9%)NoFairGlaxo Wellcome
Pan
2008
Two Sites
US
YesYesYesYesYesYesYesYes, No, Yes, NoNoNRNoFairGSK
Purhonen
2006 (A)
NR
YesYesYesYesYesYesYesYes, Yes, Yes, YesNoneNRNoFairNR
Trescha
2005
Single Center
Germany
YesYesYesYesYesYesYesYes, NR, NR, NRNRNRNoFairNR
Palonosetron
Candiotti
2008
Multiple Sites
USA
YesYesYesYesYesYesYesYes, No, Yes, NoNoYesNoFairHelsinn Healthcare SA
MGI PHARMA Inc
RS-25259
Tang
1998
Two Sites
US
YesYesYesYesYesYesYesNo, No, No, NoNRNRNoFairSyntex
Children: active- controlled trials
Ondansetron
Bach-Styles
1997
NRNRYesYesYesYesYesNo, No, No, NoUnclear, attrition NRYesNoFair
Davis, A.
1995
NRNRYesYesYesYesYesNo, No, No, NoNRYesNoFairGlaxo provided ondansetron
Davis, P.
1995
YesYesYes, but unclear if included 7 pts (6.9%) that were excluded for various reasonsYesYesYesYesYes, No, No, NoNoneUnclear if included 7 pts (6.9%) that were excluded for various reasonsNoFairNR
Litman
1995
YesNRYesYesNRYesYesNo, No, No, NoNRUnclearNoFairNR
Rose
1994
YesNRYesYesYesYesYesNo, No, No, NoNRYesNoFairNR
Splinter
1998
NRNRYes, but excluded 4 pts (1.8%) with major protocol violationsYesNRYesYesYes, No, No, NoNoneNo, excluded 4 pts (1.8%) with major protocol violationsNoFairNR
Stene
1996
YesYesYes, but excluded 12 pts (9%) with breaches in study protocolYesNRYesYesYes, No, No, NoNoneNo, excluded 41 pts (31%); 12 for protocol breaches, 29 for overnight admission due to airway concernsYes, overnight admission due to airway concernsPoorNR
Granisetron
Luisi
2006 Brazil
University Hospital
NRNRNRYesNRYesYesYes, No, No, NoUnclearNRNoPoorNR
Children: placebo-controlled trials
Ondansetron
Carnahan
1997
NRNRYesYesYesYesYesNo, No, No, NoUnclearYesNoFairNR
Cieslack
1996
YesYesYesYesNRYesYesNo, No, No, NoNRYesNoFairNR
Munro
1999
YesNRYes, but excluded 3 (3.9%) that refused medicationYesYesYesYesYes, No, No, NoNoneYes, if the 3 that didn’t take study meds are disregardedNoFairSmithKlein Beecham
Patel
1997
NRNRYes, excluded 4 pts (0.9%) who never took study medicationYesNRYesYesYes, No, No, NoNoneNo, excluded 14 (3.3%) with protocol violationsNoFairGlaxo Wellcome
Granisetron
Sennaraj
2002
YesYesYesYesYesYesYesNo, No, No, NoNRYesNoFairNR

From: Evidence Tables

Cover of Drug Class Review: Newer Antiemetics
Drug Class Review: Newer Antiemetics: Final Report Update 1 [Internet].
Peterson K, McDonagh M, Carson S, et al.
Portland (OR): Oregon Health & Science University; 2009 Jan.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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