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MRI in children given gadodiamide injection: safety and efficacy in CNS and body indications.

Abstract
The safety and efficacy of the MRI contrast medium gadodiamide injection (OMNISCAN) in children is summarised. Four open and three double-blind, multinational, multicentre comparative trials have been undertaken. Overall, 353 patients (15 days to 18 years, plus one 21 years) received gadodiamide injection, and 128 (2-18 years) received gadopentetate dimeglumine (Magnevist), intravenously at 0.1 mmol/kg body weight, to aid the identification of CNS and body lesions. Adverse events were reported in 13 (4%) patients given gadodiamide injection and 8 (6%) given gadopentetate dimeglumine; few patients reported injection-associated discomfort. The post-contrast scan gave more diagnostic information in 223 (63%) patients given gadodiamide injection (CNS and body indications). In the comparative trials, the post-contrast scan gave more diagnostic information for 91 (65%) and 82 (64%) patients given gadodiamide injection and gadopentetate dimeglumine, respectively (CNS indications only). Gadodiamide injection (0.1 mmol/kg body weight) was safe and effective in infants, children and adolescents.
AuthorsB Lundby, P Gordon, F Hugo
JournalEuropean journal of radiology (Eur J Radiol) Vol. 23 Issue 3 Pg. 190-6 (Nov 1996) ISSN: 0720-048X [Print] Ireland
PMID9003923 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article)
Chemical References
  • Contrast Media
  • Drug Combinations
  • Organometallic Compounds
  • Meglumine
  • Pentetic Acid
  • gadodiamide
  • Gadolinium
  • Gadolinium DTPA
Topics
  • Adolescent
  • Central Nervous System Diseases (diagnosis)
  • Child
  • Child, Preschool
  • Clinical Trials, Phase III as Topic
  • Contrast Media
  • Drug Combinations
  • Gadolinium (adverse effects)
  • Gadolinium DTPA
  • Humans
  • Infant
  • Infant, Newborn
  • Magnetic Resonance Imaging
  • Meglumine (adverse effects)
  • Multicenter Studies as Topic
  • Organometallic Compounds (adverse effects)
  • Pentetic Acid (adverse effects, analogs & derivatives)
  • Randomized Controlled Trials as Topic
  • Safety

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