A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen
Tong J. Gan, MD; Keith Candiotti, MD; Alparslan Turan, MD; Asokumar Buvanendran, MD; Beverly K. Philip, MD; Eugene R. Viscusi, MD; Suren Soghomonyan, MD, PhD; Sergio D. Bergese, MD
This was a Phase IV, multicenter, open-label, clinical surveillance study. It was conducted in 21 hospitals, and 300 adult hospitalized patients undergoing surgery were enrolled. Patients received 800 mg of IV ibuprofen administered over 5 – 10 minutes preoperatively. Vital signs, adverse events, and pain scores were assessed.
The authors concluded that IV Ibuprofen infused over 5 – 10 minutes at induction of anesthesia was a safe administration option for surgical patients.
Types of surgical procedures during which ibuprofen infusion was administered.
Data are given as n (%) of patients
|Hernia repair||41 (14)|
|Knee arthroplasty||27 (9)|
|Hip arthroscopy||23 (8)|
|Hip arthroplasty||20 (6)|
|Permanent spinal cord stimulation||10 (3)|
|Foot arthroplasty||7 (2)|
|Tumor resection||4 (1)|
|Intrathecal drug delivery pump||4 (1)|
|Rectocele repair||3 (1)|
|Ankle arthroscopy||3 (1)|
|Foot revision||3 (1)|
|Shoulder arthroscopy||2 (1)|
|Ankle arthrodesis||2 (1)|
|Thyroid lobectomy||2 (1)|
|Shoulder manipulation||2 (1)|
CALDOLOR must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis. CALDOLOR should not be given as an IV bolus or IM injection.1