drugset / Trial / NCT01707251
Intravenous Ibuprofen for Laparoscopic Bariatric Surgery
Phase 4
Completed
100 enrolled
Jacobi Medical Center
Cumberland Pharmaceuticals · collabSagatech Electronics Inc, Alberta, Canada · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.
Timeline
- Start
- 2012-10
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 800 mg | Intravenous |