SINGLE-DOSE, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY CROSS-OVER COMPARISON OF EXTRADURAL AND I.V. CLONIDINE IN CHRONIC PAIN

Abstract

We studied 10 patients with chronic back pain who had claimed benefit with a previous extradural dose of clonidine 150 micrograms combined with local anaesthetic. We compared a single dose of clonidine 150 micrograms given by either the extradural or i.v. route in a double-blind, randomized, double-dummy and cross-over fashion, with 80% power to detect a difference in the analgesic effect of the two routes. Pain intensity, pain relief, adverse effects, mood, sedation and vital signs were assessed by a nurse observer. I.v. clonidine produced significantly (P < 0.04) greater analgesia than extradural clonidine in one of the five analgesic outcome measures. Clonidine given by either route produced statistically significant sedation and significant decreases in arterial pressure and heart rate. In this study, extradural clonidine had no significant clinical advantages compared with i.v. clonidine; clonidine 150 micrograms by either route produced a high incidence of adverse effects.