Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research

References

• American Academy of Pediatrics, Committee on Drugs . 1992 . Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures . Pediatrics , 89 ( 6 Pt 1 ) : 1110 – 1115 .
   PubMed Web of Science ®Google Scholar
• American Academy of Pediatrics, Committee on Drugs . 2002 . Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: Addendum . Pediatrics , 110 ( 4 ) : 836 – 838 .
   PubMed Web of Science ®Google Scholar
• American Academy of Pediatrics, American Academy of Pediatric Dentistrythe Work Group on Sedation , Coté , C. J. and Wilson , S. 2006 . Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: An update . Pediatrics , 118 ( 6 ) : 2587 – 2602 .
   PubMed Web of Science ®Google Scholar
• American Academy of Pediatrics, Committee on Environmental Health . 1997 . Noise: A hazard for the fetus and newborn . Pediatrics , 100 ( 4 ) : 724 – 727 .
   PubMed Web of Science ®Google Scholar
• American Society of Anesthesiologists, Task Force on Sedation and Analgesia by Non-Anesthesiologists . 2002 . Practice guidelines for sedation and analgesia by non-anesthesiologists . Anesthesiology , 96 ( 4 ) : 1004 – 1017 .
   PubMed Web of Science ®Google Scholar
• Amundsen , L. B. , Artru , A. A. , Dager , S. R. , Shaw , D. W. W. , Friedman , S. , Sparks , B. and Dawson , G. 2005 . Propofol sedation for longitudinal pediatric neuroimaging research . Journal of Neurosurgical Anesthesiology , 17 ( 4 ) : 180 – 192 .
   PubMed Web of Science ®Google Scholar
• Battin , M. , Maalouf , E. F. , Counsell , S. , Herlihy , A. , Hall , A. , Azzopardi , D. and Edwards , A. D. 1998 . Physiological stability of preterm infants during magnetic resonance imaging . Early Human Development , 52 ( 2 ) : 101 – 110 .
   PubMed Web of Science ®Google Scholar
• Blüml , S. , Friedlich , P. , Erberich , S. , Wood , J. C. , Seri , I. and Nelson , M. D. Jr. 2004 . MR imaging of newborns by using an MR-compatible incubator with integrated radiofrequency coils: Initial experience . Radiology , 231 ( 2 ) : 594 – 601 .
   PubMed Web of Science ®Google Scholar
• Brenner , D. J. , Elliston , C. D. , Hall , E. J. and Berdon , W. E. 2001 . Estimated risks of radiation-induced fatal cancer from pediatric CT . AJR American Journal of Roentgenology , 176 ( 2 ) : 289 – 296 .
   PubMed Web of Science ®Google Scholar
• Broome , D. R. , Girguis , M. S. , Baron , P. W. , Cottrell , A. C. , Kjellin , I. and Kirk , G. A. 2007 . Gadodiamide-associated nephrogenic systemic fibrosis: Why radiologists should be concerned . AJR American Journal of Roentgenology , 188 ( 2 ) : 586 – 592 .
   PubMed Web of Science ®Google Scholar
• Coté , C. J. , Notterman , D. A. , Karl , H. W. , Weinberg , J. A. and McCloskey , C. 2000 . Adverse sedation events in pediatrics: A critical incident analysis of contributing factors . Pediatrics , 105 ( 4 Pt 1 ) : 805 – 814 .
   PubMed Web of Science ®Google Scholar
• Counter , S. A. , Olofsson , Å. , Borg , E. , Bjelke , B. , Häggström , A. and Grahn , H. F. 2000 . Analysis of magnetic resonance imaging acoustic noise generated by a 4.7 T experimental system . Acta Otolaryngologica , 120 ( 6 ) : 739 – 743 .
   PubMed Web of Science ®Google Scholar
• Cowper , S. E. , Robin , H. S. , Steinberg , S. M. , Su , L. D. , Gupta , S. and LeBoit , P. E. 2000 . Scleromyxoedema-like cutaneous diseases in renal-dialysis patients . The Lancet , 356 ( 9234 ) : 1000 – 1001 .
   PubMed Web of Science ®Google Scholar
• De Ridder , F. , De Maeseneer , M. , Stadnik , T. , Luypaert , R. and Osteaux , M. 2001 . Severe adverse reactions with contrast agents for magnetic resonance: Clinical experience in 30000 MR examinations . JBR-BTR , 84 ( 4 ) : 150 – 152 .
   PubMedGoogle Scholar
• De Vita , E. , Bainbridge , A. , Cheong , J. L. Y. , Hagmann , C. , Lombard , R. , Chong , W. K. , Wyatt , J. S. , Cady , E. B. , Ordidge , R. J. and Robertson , N. J. 2006 . Magnetic resonance imaging of neonatal encephalopathy at 4.7 Tesla: Initial experiences . Pediatrics , 118 ( 6 ) : e1812 – e1821 .
   PubMed Web of Science ®Google Scholar
• Deo , A. , Fogel , M. and Cowper , S. E. 2007 . Nephrogenic systemic fibrosis: A population study examining the relationship of disease development to gadolinium exposure . Clinical Journal of the American Society of Nephrology , 2 ( 2 ) : 264 – 267 .
   PubMed Web of Science ®Google Scholar
• Dial , S. , Silver , P. , Bock , K. and Sagy , M. 2001 . Pediatric sedation for procedures titrated to a desired degree of immobility results in unpredictable depth of sedation . Pediatric Emergency Care , 17 ( 6 ) : 414 – 420 .
   PubMed Web of Science ®Google Scholar
• Dillman , J. R. , Ellis , J. H. , Cohan , R. H. , Strouse , P. J. and Jan , S. C. 2007a . Frequency and severity of acute allergic-like reactions to gadolinium-containing IV contrast media in children and adults . AJR American Journal of Roentgenology , 189 ( 6 ) : 1533 – 1538 .
   PubMed Web of Science ®Google Scholar
• Dillman , J. R. , Strouse , P. J. , Ellis , J. H. , Cohan , R. H. and Jan , S. C. 2007b . Incidence and severity of acute allergic-like reactions to IV nonionic iodinated contrast material in children . AJR American Journal of Roentgenology , 188 ( 6 ) : 1643 – 1647 .
   PubMed Web of Science ®Google Scholar
• Downie , J. and Marshall , J. 2007 . Pediatric neuroimaging ethics . Cambridge Quarterly of Healthcare Ethics , 16 ( 2 ) : 147 – 160 .
   PubMed Web of Science ®Google Scholar
• Dudink , J. , Kerr , J. L. , Paterson , K. and Counsell , S. J. 2008 . Connecting the developing preterm brain . Early Human Development , 84 ( 12 ) : 777 – 782 .
   PubMed Web of Science ®Google Scholar
• Erberich , S. G. , Friedlich , P. , Seri , I. , Nelson , M. D. Jr. and Blüml , S. 2003 . Functional MRI in neonates using neonatal head coil and MR compatible incubator . NeuroImage , 20 ( 2 ) : 683 – 692 .
   PubMed Web of Science ®Google Scholar
• Gooding , C. A. , Berdon , W. E. , Brodeur , A. E. and Rowen , M. 1975 . Adverse reactions to intravenous pyelography in children . AJR American Journal of Roentgenology , 123 ( 4 ) : 802 – 804 .
   Web of Science ®Google Scholar
• Grobner , T. 2006 . Gadolinium–-A specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? . Nephrology Dialysis Transplantation , 21 ( 4 ) : 1104 – 1108 .
   PubMed Web of Science ®Google Scholar
• Hadskis , M. , Kenny , N. , Downie , J. , Schmidt , M. and D'Arcy , R. 2008 . The therapeutic misconception: A threat to valid parental consent for pediatric neuroimaging research . Accountability in Research , 15 ( 3 ) : 133 – 151 .
   PubMed Web of Science ®Google Scholar
• Hallowell , L. M. , Stewart , S. E. , de Amorim e Silva , C. T. and Ditchfield , M. R. 2008 . Reviewing the process of preparing children for MRI . Pediatric Radiology , 38 ( 3 ) : 271 – 279 .
   PubMed Web of Science ®Google Scholar
• Kanal , E. , Borgstede , J. P. , Barkovich , A. J. , Bell , C. , Bradley , W. G. , Felmlee , J. P. , Froelich , J. W. , Kaminski , E. M. , Keeler , E. K. , Lester , J. W. , Scoumis , E. A. , Zaremba , L. A. and Zinninger , M. D. 2002 . American College of Radiology White Paper on MR Safety . AJR American Journal of Roentgenology , 178 ( 6 ) : 1335 – 1347 .
   PubMedGoogle Scholar
• Kanal , E. , Borgstede , J. P. , Barkovich , A. J. , Bell , C. , Bradley , W. G. , Felmlee , J. P. , Froelich , J. W. , Kaminski , E. M. , Keeler , E. K. , Lester , J. W. , Scoumis , E. A. , Zaremba , L. A. and Zinninger , M. D. 2003 . ACR Blue Ribbon Panel response to the ACR commentary by Shellock and Crues on the ACR white paper on MR safety . AJR American Journal of Roentgenology , 180 ( 1 ) : 31 – 35 .
   PubMed Web of Science ®Google Scholar
• Kanal , E. , Borgstede , J. P. , Barkovich , A. J. , Bell , C. , Bradley , W. G. , Etheridge , S. , Felmlee , J. P. , Froelich , J. W. , Hayden , J. , Kaminski , E. M. , Lester , J. D. Jr , Scoumis , E. A. , Zaremba , L. A. and Zinninger , M. D. 2004 . American College of Radiology White Paper on MR Safety: 2004 update and revisions . AJR American Journal of Roentgenology , 182 ( 5 ) : 1111 – 1114 .
   PubMed Web of Science ®Google Scholar
• Kanal , E. , Barkovich , A. J. , Bell , C. , Borgstede , J. P. , Bradley , W. G. Jr , Froelich , J. W. , Gilk , T. , Gimbel , J. R. , Gosbee , J. , Kuhni-Kaminski , E. , Lester , J. W. Jr , Nyenhuis , J. , Parag , Y. , Schaefer , D. J. , Sebek-Scoumis , E. A. , Weinreb , J. , Zaremba , L. A. , Wilcox , P. , Lucey , L. , Sass , N. and for the ACR Blue Ribbon Panel on MR Safety . 2007 . ACR guidance document for safe MR practices: 2007 . AJR American Journal of Roentgenology , 188 ( 6 ) : 1447 – 1474 .
   PubMed Web of Science ®Google Scholar
• Kao , S. C. , Adamson , S. D. , Tatman , L. H. and Berbaum , K. S. 1999 . A survey of post-discharge side effects of conscious sedation using chloral hydrate in pediatric CT and MR imaging . Pediatric Radiology , 29 ( 4 ) : 287 – 290 .
   PubMed Web of Science ®Google Scholar
• Kangarlu , A. , Baudendistel , K. T. , Heverhagen , J. T. and Knopp , M. V. 2004 . Klinische Hoch- und Ultrahochfeld-MR und ihre Wechselwirkung mit biologischen Systemen . Der Radiologe , 44 ( 1 ) : 19 – 30 .
   PubMedGoogle Scholar
• King , W. K. , Stockwell , J. A. , DeGuzman , M. A. , Simon , H. K. and Khan , N. S. 2006 . Evaluation of a pediatric-sedation service for common diagnostic procedures . Academic Emergency Medicine , 13 ( 6 ) : 673 – 676 .
   PubMed Web of Science ®Google Scholar
• Li , A. , Wong , C. S. , Wong , M. K. , Lee , C. M. and Au Yeung , M. C. 2006 . Acute adverse reactions to magnetic resonance contrast media–gadolinium chelates . The British Journal of Radiology , 79 ( 941 ) : 368 – 371 .
   PubMed Web of Science ®Google Scholar
• Long , J. G. , Lucey , J. F. and Philip , A. G. S. 1980 . Noise and hypoxemia in the intensive care nursery . Pediatrics , 65 ( 1 ) : 143 – 145 .
   PubMed Web of Science ®Google Scholar
• Lundby , B. , Gordon , P. and Hugo , F. 1996 . MRI in children given gadodiamide injection: Safety and efficacy in CNS and body indications . European Journal of Radiology , 23 ( 3 ) : 190 – 196 .
   PubMed Web of Science ®Google Scholar
• Malviya , S. , Voepel-Lewis , T. , Prochaska , G. and Tait , A. R. 2000 . Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children . Pediatrics , 105 ( 3 ) : E42
   PubMed Web of Science ®Google Scholar
• Malviya , S. , Voepel-Lewis , T. , Tait , A. R. , Reynolds , P. I. , Gujar , S. K. , Gebarski , S. S. and Eldevik , O. P. 2004 . Pentobarbital vs chloral hydrate for sedation of children undergoing MRI: Efficacy and recovery characteristics . Pediatric Anesthesia , 14 ( 7 ) : 589 – 595 .
   PubMed Web of Science ®Google Scholar
• Marshall , J. , Martin , T. , Downie , J. and Malisza , K. 2007 . A comprehensive analysis of MRI research risks: In support of full disclosure . The Canadian Journal of Neurological Sciences , 34 ( 1 ) : 11 – 17 .
   PubMed Web of Science ®Google Scholar
• Martin , D. R. 2008 . Nephrogenic systemic fibrosis . Pediatric Radiology , 38 ( Suppl 1 ) : S125 – S129 .
   PubMedGoogle Scholar
• Mason , K. P. , Sanborn , P. , Zurakowski , D. , Karian , V. E. , Connor , L. , Fontaine , P. J. and Burrows , P. E. 2004a . Superiority of pentobarbital versus chloral hydrate for sedation in infants during imaging . Radiology , 230 ( 2 ) : 537 – 542 .
   PubMed Web of Science ®Google Scholar
• Mason , K. P. , Zurakowski , D. , Connor , L. , Karian , V. E. , Fontaine , P. J. , Sanborn , P. A. and Burrows , P. E. 2004b . Infant sedation for MR imaging and CT: Oral versus intravenous pentobarbital . Radiology , 233 ( 3 ) : 723 – 728 .
   PubMed Web of Science ®Google Scholar
• Mendichovszky , I. A. , Marks , S. D. , Simcock , C. M. and Olsen , Ø. E. 2008 . Gadolinium and nephrogenic systemic fibrosis: Time to tighten practice . Pediatric Radiology , 38 ( 5 ) : 489 – 496 .
   PubMed Web of Science ®Google Scholar
• Mendoza , F. A. , Artlett , C. M. , Sandorfi , N. , Latinis , K. , Piera-Velazquez , S. and Jimenez , S. A. 2006 . Description of 12 cases of nephrogenic fibrosing dermopathy and review of the literature . Seminars in Arthritis and Rheumatism , 35 ( 4 ) : 238 – 249 .
   PubMed Web of Science ®Google Scholar
• Murphy , K. J. , Brunberg , J. A. and Cohan , R. H. 1996 . Adverse reactions to gadolinium contrast media: A review of 36 cases . AJR American Journal of Roentgenology , 167 ( 4 ) : 847 – 849 .
   PubMed Web of Science ®Google Scholar
• Othersen , J. B. , Maize , J. C. Jr , Woolson , R. F. and Budisavljevic , M. N. 2007 . Nephrogenic systemic fibrosis after exposure to gadolinium in patients with renal failure . Nephrology Dialysis Transplantation , 22 ( 11 ) : 3179 – 3185 .
   PubMed Web of Science ®Google Scholar
• Penfield , J. G. 2008 . Nephrogenic systemic fibrosis and the use of gadolinium-based contrast agents . Pediatric Nephrology , 23 ( 12 ) : 2121 – 2129 .
   PubMed Web of Science ®Google Scholar
• Philbin , M. K. , Taber , K. H. and Hayman , L. A. 1996 . Preliminary report: Changes in vital signs of term newborns during MR . AJNR American Journal of Neuroradiology , 17 ( 6 ) : 1033 – 1036 .
   PubMed Web of Science ®Google Scholar
• Radiological Society of North America . 2008 . 9.4T promises greater function, new purpose for MR . RSNA News , 18 ( 7 ) : 6 – 7 .
   Google Scholar
• Rodolà , F. and Anastasi , F. 2004 . A runny nose: An unexpected ferromagnetic foreign body in an unexpected place . European Review for Medical and Pharmacological Sciences , 8 ( 4 ) : 139 – 141 .
   PubMedGoogle Scholar
• Sanborn , P. A. , Michna , E. , Zurakowski , D. , Burrows , P. E. , Fontaine , P. J. , Connor , L. and Mason , K. P. 2005 . Adverse cardiovascular and respiratory events during sedation of pediatric patients for imaging examinations . Radiology , 237 ( 1 ) : 288 – 294 .
   PubMed Web of Science ®Google Scholar
• Shellock , F. G. and Crues , J. V. III. 2002 . MR safety and the American College of Radiology White Paper . AJR American Journal of Roentgenology , 178 ( 6 ) : 1349 – 1352 .
   PubMed Web of Science ®Google Scholar
• Shellock , F. G. and Crues , J. V. 2004 . MR procedures: Biologic effects, safety, and patient care . Radiology , 232 ( 3 ) : 635 – 652 .
   PubMed Web of Science ®Google Scholar
• Smart , G. 1997 . Helping children relax during magnetic resonance imaging . MCN The American Journal of Maternal/Child Nursing , 22 ( 5 ) : 237 – 241 .
   Google Scholar
• Stokowski , L. A. 2005 . Ensuring safety for infants undergoing magnetic resonance imaging . Advances in Neonatal Care , 5 ( 1 ) : 14 – 27 .
   PubMedGoogle Scholar
• Steen , H. and Schwenger , V. 2007 . Good MRI images: To gad or not to gad? . Pediatric Nephrology , 22 ( 9 ) : 1239 – 1242 .
   PubMed Web of Science ®Google Scholar
• Taber , K. H. , Hayman , L. A. , Northrup , S. R. and Maturi , L. 1998 . Vital sign changes during infant magnetic resonance examinations . Journal of Magnetic Resonance Imaging , 8 ( 6 ) : 1252 – 1256 .
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration, Center for Devices and Radiological Health. Guidance for industry and FDA staff: Criteria for significant risk investigations of magnetic resonance diagnostic devices. July 14, 2003. Available at http://www.fda.gov/cdrh/ode/guidance/793.html (Accessed: 23 February 2009 ).
   Google Scholar
• U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Information for health care professionals: Gadolinium-based contrast agents for magnetic resonance imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance). June 4, 2008. Available at http://fda.gov/cder/drug/InfoSheets/HCP/gcca_200705.htm (Accessed: 23 February 2009 ).
   Google Scholar
• Whitby , E. H. , Griffiths , P. D. , Lonneker-Lammers , T. , Srinivasan , R. , Connolly , D. J. A. , Capener , D. and Paley , M. N. J. 2004 . Ultrafast magnetic resonance imaging of the neonate in a magnetic resonance-compatible incubator with a built-in coil . Pediatrics , 113 ( 2 ) : e150 – e152 .
   PubMed Web of Science ®Google Scholar
• Williams , L.-A. , DeVito , T. J. , Winter , J. D. , Orr , T. N. , Thompson , R. T. and Gelman , N. 2007 . Optimization of 3D MP-RAGE for neonatal brain imaging at 3.0 T . Magnetic Resonance Imaging , 25 ( 8 ) : 1162 – 1170 .
   PubMed Web of Science ®Google Scholar
• Yang , M. , Christoforidis , G. , Abduljali , A. and Beversdorf , D. 2006 . Vital signs investigation in subjects undergoing MR imaging at 8T . AJNR American Journal of Neuroradiology , 27 ( 4 ) : 922 – 928 .
   PubMed Web of Science ®Google Scholar