Safety of greater than 3 days of therapy with parecoxib injection in the management of postoperative pain

Introduction:

Multi-modal pain management that includes parenteral non-opioid analgesics is strongly recommended in fast-track surgery. ^1,2 Guidelines recommend NSAIDs and coxibs to improve postoperative analgesia, decrease opioid consumption and side effects. ³  Parecoxib is an injectible coxib used to treat postoperative pain.

Most patients tolerate oral administration within 2-3 days following surgery.  However, in certain surgeries (i.e. gastrointestinal) or when patients are debilitated, parenteral administration of analgesics may be needed beyond 3 days post-surgery. 

Objectives:

To assess the clinical safety data of >3 days therapy with parecoxib in the management of postoperative pain. 

Study Design: A retrospective review of the parecoxib clinical trial database.

Methods:

Duration of therapy was assessed in the 28 trials.  In 3 trials patients received treatment for postoperative pain for >3 days.  Adverse events (AE) were pooled for those receiving parecoxib >3 days and compared to the placebo group.  Specific analyses were performed for cardiovascular (CV) thrombotic/embolic, serious gastrointestinal (GI) and renal events.

Results:

A total of 358 patients received parecoxib for >3 days: 63/320 (19.7%) in a hip arthoplasty study, 92/211 (43.6%) in a gynecological surgery/hysterectomy study, and 203/525 (38.7%) in a general surgery trial.  Any AE was reported for 10.3% (37/358) and 9.7% (31/318) of parecoxib and placebo treated patients, respectively.  AE were similar between groups: CV disorders (0.6% parecoxib, 0.6% placebo), nervous system (0.8%, 0.6%), dizziness (0.6%,0%), headache (0.3%,0.6%), insomnia (0.6%,0.6%), and skin disorders (0.8%,0.9%).  In the Specific AE Analyses, there were no CV thrombotic/embolic events or GI perforations/ulcerations/hemorrhage/obstructions in either group.  There was 1 report of oliguria in the parecoxib group. 

Conclusions:

Surgical patients who received parecoxib for >3 days postoperatively reported similar AE to those receiving placebo in 3 clinical trials.

1. Scott MJ et al. Acta Anaes Scand 2015.
2. Nanavati AJ, Prabhakar S.  Anesth Essays Res. 2014;8(2):127-33.
3. Feldheiser A et al. Acta Anaes Scand 2015.