A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients

Abstract

Objective: To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients.

Design: This was a multi-center, randomized, double-blind placebo-controlled trial.

Setting: This study was completed at eight hospitals; six in the United States and two in South Africa.

Patients: A total of 185 adult patients undergoing elective orthopedic surgery.

Interventions: Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue.

Outcome measures: Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed.

Results: In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events.

Conclusion: Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial.

Figures

Figure 1

Study timeline.

Figure 3

VASR scores, over time, post surgery-pain at rest was assessed by VAS at the first immediate post-operative opportunity (mean 2.81 hours) out to study hour 28 in the IV-ibuprofen and placebo treatment groups. Error bars denote SEM.

Figure 2

VASM scores, over time, post surgery-pain with movement was assessed by VAS at the first immediate post-operative opportunity (mean 2.81 hours) out to study hour 28 in the IV-ibuprofen and placebo treatment groups. Error bars denote SEM.