ISSN: 2155-6148
Douglas A Hamilton
Tanzania
Research Article
Clinical and Laboratory Hematologic Findings in Patients Receiving Repeated-Dose Injectable HPBCD-Diclofenac for Acute Postoperative Pain: Pooled Analysis of Two Randomized Controlled Phase III Clinical Trials
Author(s): Tong J Gan, Neil Singla, Stephen E Daniels, Douglas A Hamilton, Peter G Lacouture, Olufunmibi Johnson, Christian RD Reyes and Daniel B Carr
Tong J Gan, Neil Singla, Stephen E Daniels, Douglas A Hamilton, Peter G Lacouture, Olufunmibi Johnson, Christian RD Reyes and Daniel B Carr
Objective: While the non-steroidal anti-inflammatory drugs (NSAIDs) represent an important option for the management of acute postoperative pain, their use can be limited due to potential safety concerns, including bleeding risks. This study examined the bleeding-related safety of injectable diclofenac formulated with hydroxypropyl-β-cyclodextrin (HPβCD-diclofenac) when used for postoperative pain management.
Methods: Data from two randomized, double-blind, placebo- and active comparator-controlled phase III trials were pooled. Patients in both studies received HPβCD-diclofenac, placebo, or the active comparator ketorolac via intravenous injection every 6 hours for ≤ 5 days following abdominal/pelvic or orthopedic surgery. Bleeding adverse events (AEs) were evaluated through the treatment period and follow-up (≤ 37 days).. View More»
DOI:
10.4172/2155-6148.1000538