• Pain · Mar 2004

    Randomized Controlled Trial Clinical Trial

    Safety and efficacy of intranasal ketamine for the treatment of breakthrough pain in patients with chronic pain: a randomized, double-blind, placebo-controlled, crossover study.

    • Daniel B Carr, Leonidas C Goudas, William T Denman, Daniel Brookoff, Peter S Staats, Loralie Brennen, Geoff Green, Randi Albin, Douglas Hamilton, Mark C Rogers, Leonard Firestone, Philip T Lavin, and Fred Mermelstein.
    • Department of Anesthesia, Box 298, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111, USA. daniel.carr@tufts.edu
    • Pain. 2004 Mar 1;108(1-2):17-27.

    AbstractFew placebo-controlled trials have investigated the treatment of breakthrough pain (BTP) in patients with chronic pain. We evaluated the efficacy and safety of intranasal ketamine for BTP in a randomized, double-blind, placebo-controlled, crossover trial. Twenty patients with chronic pain and at least two spontaneous BTP episodes daily self-administered up to five doses of intranasal ketamine or placebo at the onset of a spontaneous BTP episode (pain intensity > or =5 on a 0-10 scale). Two BTP episodes at least 48 h apart were treated with either ketamine or placebo. Patients reported significantly lower BTP intensity following intranasal ketamine than after placebo (P < 0.0001) with pain relief within 10 min of dosing and lasting for up to 60 min. No patient in the ketamine group required his/her usual rescue medication to treat the BTP episode, while seven out of 20 (35%) patients in placebo group did (P = 0.0135). Intranasal ketamine was well tolerated with no serious adverse events. After ketamine administration, four patients reported a transient change in taste, one patient reported rhinorrhea, one patient reported nasal passage irritation, and two patients experienced transient elevation in blood pressure. A side effect questionnaire administered 60 min and 24 h after drug or placebo administration elicited no reports of auditory or visual hallucinations. These data suggest that intranasal administration of ketamine provides rapid, safe and effective relief for BTP.

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