Trazodone hydrochloride in the treatment of dysesthetic pain in traumatic myelopathy: a randomized, double-blind, placebo-controlled study.

Dysesthetic pain following traumatic myelopathy is characterized by diffuse burning and tingling sensations distal to the level of spinal injury. The dysesthetic pain syndrome (DPS) can compromise performance of functional abilities and inhibit participation in rehabilitation programs. Recent laboratory evidence suggests that antidepressant medications with selective inhibition of serotonin reuptake in the brain may be associated with superior analgesic effect compared to such non-selective agents as amitriptyline. Trazodone hydrochloride is a potent presynaptic serotonin reuptake blocker with few anticholinergic and cardiovascular side effects. This study was a randomized, double-blind, placebo-controlled trial of trazodone hydrochloride for the treatment of DPS. Following a 2-week placebo lead-in period, patients were randomized to a 6-week course of 150 mg trazodone hydrochloride/day or placebo. Evaluations of pain quality and intensity were performed at 2-week intervals, utilizing the McGill Pain Questionnaire, Sternbach Pain Intensity Scale, and Zung Pain and Distress Index. Neurologic examination and assessment of side effects were performed at each evaluation session. No significant changes were noted in reported pain measures between patients allocated to the active drug group and those given placebo during the course of the protocol. However, significantly more patients randomized to trazodone complained of side effects and prematurely terminated their participation in the study. The results of this investigation are consistent with those of other earlier trials which indicate that such antidepressant medications as trazodone hydrochloride which selectively inhibit presynaptic reuptake of serotonin, may not be effective in the control of certain pain syndromes. These results do not preclude the possible utility of these agents in the treatment of other pain syndromes or at higher doses than previously studied.

RCT Entities:   Population Interventions Outcomes