Document Detail


Rapid bolus injection of gadopentetate dimeglumine: absence of side effects in normal volunteers.
MedLine Citation:
PMID:  2120987     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The safety and tolerance of gadopentetate dimeglumine 0.1 mmol/kg when injected at a bolus rate (10 ml/15 sec; four times the recommended rate) was studied in 12 normal men between the ages of 20 and 36 years. Each of the subjects received a single injection of either gadopentetate dimeglumine (0.2 ml/kg) or a placebo (normal saline, 0.2 ml/kg), followed by a 7-day washout and a single injection of the alternative treatment (six subjects per sequence). Measurement parameters included blood pressure, pulse rate, ECG, cardiographic rhythm strips, hematology and blood chemistry evaluations, physical examinations, and adverse drug experiences. Variations of greater than or equal to +/- 15 mm Hg in diastolic blood pressure and greater than or equal to +/- 15 beats per min in heart rate were observed in some subjects after injection of either gadopentetate dimeglumine or the placebo, but no clinically significant changes from baseline were observed for any parameter. Post-gadopentetate dimeglumine results were not significantly different statistically from post-placebo results. No adverse experiences were reported for any subject. It is concluded that gadopentetate dimeglumine is safe and well tolerated when administered to normal men at a rapid injection rate of 10 ml/15 sec.
Authors:
F K Kashanian; H A Goldstein; R F Blumetti; W L Holyoak; F P Hugo; M Dolker
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  AJNR. American journal of neuroradiology     Volume:  11     ISSN:  0195-6108     ISO Abbreviation:  AJNR Am J Neuroradiol     Publication Date:    1990 Sep-Oct
Date Detail:
Created Date:  1990-11-16     Completed Date:  1990-11-16     Revised Date:  2008-02-14    
Medline Journal Info:
Nlm Unique ID:  8003708     Medline TA:  AJNR Am J Neuroradiol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  853-6     Citation Subset:  IM    
Affiliation:
Berlex Laboratories, Inc., Wayne, NJ 07470.
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MeSH Terms
Descriptor/Qualifier:
Adult
Blood Pressure / drug effects
Double-Blind Method
Electrocardiography
Gadolinium DTPA
Heart Rate / drug effects
Humans
Injections, Intravenous
Male
Organometallic Compounds / administration & dosage,  adverse effects,  diagnostic use*
Pentetic Acid / administration & dosage,  adverse effects,  diagnostic use*
Reference Values
Chemical
Reg. No./Substance:
0/Organometallic Compounds; 67-43-6/Pentetic Acid; 80529-93-7/Gadolinium DTPA

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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