Document Detail

Diagnostic utility of flumazenil in coma with suspected poisoning: a double blind, randomised controlled study.
MedLine Citation:
PMID:  1980218     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the diagnostic value and safety of the benzodiazepine antagonist flumazenil in patients with coma of unclear origin with suspected poisoning. DESIGN: Double blind, placebo controlled, randomised study. SETTING: Intensive care unit at a major teaching hospital. PATIENTS: 105 Unconscious adults admitted consecutively with suspected drug overdosage during 18 months from a total of 362 cases of poisoning. Exclusion criteria were pregnancy, epilepsy, obvious poisoning with drugs identified unequivocally from information from relatives or others as other than benzodiazepines, and coma score greater than 10 on a scale graded from 4 to 20. Patients were allocated randomly to receive flumazenil (21 men and 32 women) or placebo (25 men and 27 women). INTERVENTIONS: Intravenous injection of flumazenil (10 ml, 0.1 mg/ml) or placebo (10 ml vehicle alone) given double blind over three minutes. MAIN OUTCOME MEASURES: Serum and urine concentrations of benzodiazepines, antidepressants, and several other agents; blood gas tensions; standardised evaluation on admission and five minutes after the injection by means of coma scale score and urgent diagnostic or therapeutic interventions indicated according to the history and clinical examination; standardised interview after the injection to try to ascertain further information; and adverse reactions. RESULTS: Benzodiazepines were found in the serum in 36 of the 53 patients in the flumazenil group and in 37 of the 52 who received placebo. The average coma scale score increased significantly after injection in the flumazenil group (6.4 v 12.1, p less than 0.001) but not in the placebo group. In the flumazenil group several interventions were rendered unnecessary by the injection: gastric lavage and urinary catheterisation (19 patients each), intubation (21), artificial ventilation and computed tomography of the brain (three patients each), blood culture and lumbar puncture (one patient each), and electroencephalography (two). In the placebo group the indications for these procedures did not change in any patient after injection. The 95% confidence interval for the difference in reduction of the frequency of indications for gastric lavage after injection between the two groups was 21% to 51%, that for intubation 25% to 55%, and that for urinary catheterisation 21% to 51%. In the flumazenil group 21 patients gave valuable information on their drug ingestion within 10 minutes after injection compared with only one in the placebo group (p less than 0.001). Nine adverse reactions were recorded in the flumazenil group, eight of which were graded as mild and one severe. The safety of the antagonist was acceptable, even though 60% of the patients in the flumazenil group had multiple drug poisoning including benzodiazepine. No epileptic seizures or arrhythmias were recorded. CONCLUSION: Flumazenil is a valuable and safe differential diagnostic tool in unclear cases of multiple drug poisoning.
J H?jer; S Baehrendtz; G Matell; L L Gustafsson
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  BMJ (Clinical research ed.)     Volume:  301     ISSN:  0959-8138     ISO Abbreviation:  BMJ     Publication Date:  1990 Dec 
Date Detail:
Created Date:  1991-02-26     Completed Date:  1991-02-26     Revised Date:  2010-03-24    
Medline Journal Info:
Nlm Unique ID:  8900488     Medline TA:  BMJ     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1308-11     Citation Subset:  AIM; IM    
Department of Internal Medicine, Southern Hospital, Stockholm, Sweden.
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MeSH Terms
Aged, 80 and over
Anti-Anxiety Agents / blood,  poisoning
Antidepressive Agents / blood,  poisoning
Coma / blood,  etiology*,  therapy
Double-Blind Method
Flumazenil / adverse effects,  diagnostic use*
Middle Aged
Poisoning / blood,  diagnosis*,  therapy
Reg. No./Substance:
0/Anti-Anxiety Agents; 0/Antidepressive Agents; 78755-81-4/Flumazenil
Comment In:
BMJ. 1991 Feb 2;302(6771):292   [PMID:  1998806 ]
BMJ. 1991 Jan 26;302(6770):238   [PMID:  1998777 ]

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