title: 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.
authors.affiliation: Nycomed Imaging AS, Torshov, Oslo, Norway.
authors.forename: B
authors.initials: B
authors.lastname: Lundby
authors.forename: P
authors.initials: P
authors.lastname: Gordon
authors.forename: F
authors.initials: F
authors.lastname: Hugo
mesh_terms: D000293:Adolescent; D002493:Central Nervous System Diseases / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D017326:Clinical Trials, Phase III as Topic; D003287:Contrast Media; D004338:Drug Combinations; D005682:Gadolinium / Q000009:adverse effects; D019786:Gadolinium DTPA; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008279:Magnetic Resonance Imaging; D008536:Meglumine / Q000009:adverse effects; D015337:Multicenter Studies as Topic; D009942:Organometallic Compounds / Q000009:adverse effects; D004369:Pentetic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D016032:Randomized Controlled Trials as Topic; D012449:Safety
chemical_list: D003287:Contrast Media; D004338:Drug Combinations; D009942:Organometallic Compounds; D008536:Meglumine; D004369:Pentetic Acid; C064925:gadodiamide; D005682:Gadolinium; D019786:Gadolinium DTPA