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.
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Authors | B Lundby, P Gordon, F Hugo |
Journal | European journal of radiology
(Eur J Radiol)
Vol. 23
Issue 3
Pg. 190-6
(Nov 1996)
ISSN: 0720-048X [Print] Ireland |
PMID | 9003923
(Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article)
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Chemical References |
- Contrast Media
- Drug Combinations
- Organometallic Compounds
- Meglumine
- Pentetic Acid
- gadodiamide
- Gadolinium
- Gadolinium DTPA
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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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