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.
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.
Carr
Daniel B
DB
Department of Anesthesia, Box 298, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111, USA. daniel.carr@tufts.edu
Goudas
Leonidas C
LC
Denman
William T
WT
Brookoff
Daniel
D
Staats
Peter S
PS
Brennen
Loralie
L
Green
Geoff
G
Albin
Randi
R
Hamilton
Douglas
D
Rogers
Mark C
MC
Firestone
Leonard
L
Lavin
Philip T
PT
Mermelstein
Fred
F
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
D000700:Analgesics; D000701:Analgesics, Opioid; D010919:Placebos; D007649:Ketamine