Preoperative rofecoxib oral suspension as an analgesic adjunct after lower abdominal surgery: the effects on effort-dependent pain and pulmonary function.

UNLABELLED: Rofecoxib is a selective cyclooxygenase-2 inhibitor that reduces pain and inflammation without inhibiting platelet function. We examined its effects on effort-dependent pain, postoperative morphine requirements, and pulmonary function in 48 patients recovering from open abdominal surgery. Spirometric measurement of forced expiratory volume(1) and vital capacity (FVC) were assessed preoperatively. One hour before the induction of a standardized general anesthetic, patients were given either placebo oral suspension (Group A), or rofecoxib oral suspension (25 mg [Group B] or 50 mg [Group C]) in a double-blinded manner. Postoperative pain control was provided with IV morphine in the postanesthesia care unit and IV-patient-controlled analgesia morphine on the patient care unit. Morphine dose, pain intensity at rest, and pain after respiratory effort (postoperative spirometry) were assessed at 12 and 24 h after study drug administration. The patient-controlled analgesia morphine dose at 24 h was reduced 44% in Group B (30.3 +/- 17.5 mg) and 59% in Group C (22.1 +/- 16.5 mg) versus Group A (53.7 +/- 31.1 mg); P < 0.01 (A versus B). At 12 h, pain scores at rest and after spirometry were lower in Groups B and C than in A (P < 0.05). At 24 h, resting pain scores were lowest in Group C (P < 0.05). Twelve-hour FVC was best preserved in Group C (P < 0.03). There were no inter-group differences in adverse effects or perioperative blood loss. Rofecoxib oral suspension provided a morphine-sparing effect, as well as improvements in pain control and 12-h FVC in patients recovering from open abdominal surgery. IMPLICATIONS: Rofecoxib belongs to class of analgesics known as cyclooxygenase-2 inhibitors that reduce pain and inflammation with less risk of bleeding than standard nonsteroidal antiinflammatory drugs. We found that patients treated with rofecoxib 25 or 50 mg before open abdominal surgery required less IV morphine during the first day of recovery. Despite reductions in morphine requirements, rofecoxib-treated patients reported lower pain intensity scores at rest and after a vigorous cough. In the 50-mg group, improvements in pain control correlated with greater preservation of baseline cough effectiveness (vital capacity) at 12 h. These findings may offer clinical advantages in patients with preexisting pulmonary disease.

RCT Entities:   Population Interventions Outcomes