{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":28,"description":"Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4 mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2 mg every 2 hours and oral 2-4 mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.\n\nIV Caldolor (Ibuprofen): Compare addition of IV Caldolor (ibuprofen) intraoperatively and postoperatively against IV placebo added intraoperatively and postoperatively.","id":"EG000","otherNumAffected":2,"otherNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"title":"Opioid-sparing Group"},{"deathsNumAffected":0,"deathsNumAtRisk":34,"description":"IV placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2 mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.\n\nIV placebo: Compare addition of IV placebo intraoperatively and postoperatively against IV Caldolor (ibuprofen) added intraoperatively and postoperatively.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":34,"seriousNumAffected":2,"seriousNumAtRisk":34,"title":"Standard Treatment Group"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"elevated level of potassium (K+) in the blood serum. Normal potassium levels are between 3.5 and 5.0 mmol/L (3.5 and 5.0 mEq/L) with levels above 5.5 mmol/L defined as hyperkalemia.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":34,"numEvents":0}],"term":"hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"I.V. fluid or medications leak into the surrounding tissue.","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":34,"numEvents":0}],"term":"burning at IV site"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by bleeding from the nose.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Epistaxis"}],"timeFrame":"surgery date until hospital discharge (average of 2 days)"}