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. 2010 Jan 20;2010(1):CD003974. doi: 10.1002/14651858.CD003974.pub3

Najnigier 1997.

Methods Design: three group parallel trial 
 Purpose: examine the preventive effect of ondansetron on postoperative nausea
Participants Patients: in‐patients undergoing laparoscopic cholecystectomy 
 Baseline comparability: NS
Interventions Placebo: tablets without ondansetron 
 Untreated: no tablets 
 Experimental: tablets with ondansetron 
 (Co‐intervention: NS)
Outcomes Number of patients with nausea 
 Number of patients with vomiting
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk NS
Allocation concealment? Unclear risk NS
Blinding? 
 Treatment provider Low risk Very likely a double‐blind study
Blinding? 
 Outcome assessor Unclear risk Not relevant as patient reported outcome
Incomplete outcome data addressed? 
 All outcomes Low risk Drop‐out < 15%
Free of selective reporting? Unclear risk No protocol available
Free of other bias? Low risk  
No signs of variance inequality or skewness? Unclear risk Not relevant (binary outcome)
Trial size > 49? Low risk N = 60
Clearly concealed allocation + trial size > 49 + drop‐out max 15% High risk Allocation not clearly concealed