title: 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.
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 > 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.
authors.affiliation: Department of Anesthesia, Box 298, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111, USA. daniel.carr@tufts.edu
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Carr
authors.forename: Leonidas C
authors.initials: LC
authors.lastname: Goudas
authors.forename: William T
authors.initials: WT
authors.lastname: Denman
authors.forename: Daniel
authors.initials: D
authors.lastname: Brookoff
authors.forename: Peter S
authors.initials: PS
authors.lastname: Staats
authors.forename: Loralie
authors.initials: L
authors.lastname: Brennen
authors.forename: Geoff
authors.initials: G
authors.lastname: Green
authors.forename: Randi
authors.initials: R
authors.lastname: Albin
authors.forename: Douglas
authors.initials: D
authors.lastname: Hamilton
authors.forename: Mark C
authors.initials: MC
authors.lastname: Rogers
authors.forename: Leonard
authors.initials: L
authors.lastname: Firestone
authors.forename: Philip T
authors.initials: PT
authors.lastname: Lavin
authors.forename: Fred
authors.initials: F
authors.lastname: Mermelstein
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D000701:Analgesics, Opioid / Q000008:administration & dosage; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007649:Ketamine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010919:Placebos; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000701:Analgesics, Opioid; D010919:Placebos; D007649:Ketamine