Evaluation of the analgesic effects of duloxetine in burn patients: An open-label randomized controlled trial.

OBJECTIVES

To evaluate efficacy of addition of duloxetine to usual analgesic regimens in management of burn pain.

METHODS

In a 3-week open label randomized controlled trial, burn patients were assigned to the intervention (duloxetine 60mg/day+usual analgesic regimens) or control group (usual analgesic regimens: morphine±acetaminophen±gabapentin). Intensity and quality of background pain and severity of procedural pain were evaluated using neuropathic pain scale (NPS) and visual analog scale (VAS), respectively. The primary outcome measure was "intensity" item of the NPS (evaluating intensity of the background pain).

RESULTS

Forty six patients (age: 35.5±6.3 years, TBSA: 36.7±15%) (23 per group) completed the study. At baseline, scores of the "intensity" item were 9.13±1.42 and 9.13±1.86 (P=1) in the intervention and control group, respectively. Comparison of difference in mean changes from baseline to the end of the study showed that addition of duloxetine only significantly reduced the scores of the "intensity" {1.74 (95% CI: 0.61 to 2.86); P=0.003}, and "hot" {1.39 (95% CI: 0.166 to 2.614) P=0.02} items and score of the VAS {2.13 (95% CI: 1.476 to 2.784) P<0.001}. The most reported adverse effects were nausea and insomnia in the both groups.

CONCLUSION

Addition of duloxetine may increase efficacy of the other analgesics in reduction of the burn pain.