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, Fred Mermelstein

Research output: Contribution to journalArticle

Abstract

Few 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 ≥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.

Original languageEnglish (US)
Pages (from-to)17-27
Number of pages11
JournalPain
Volume108
Issue number1-2
DOIs
StatePublished - Mar 2004

Keywords

  • Breakthrough
  • Chronic
  • Intranasal
  • Ketamine
  • Pain
  • Randomized controlled trial

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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  • Cite this

    Carr, D. B., Goudas, L. C., Denman, W. T., Brookoff, D., Staats, P. S., Brennen, L., Green, G., Albin, R., Hamilton, D., Rogers, M. C., Firestone, L., Lavin, P. T., & Mermelstein, F. (2004). 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. Pain, 108(1-2), 17-27. https://doi.org/10.1016/j.pain.2003.07.001