Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: Methodological issues of a randomized controlled trial

Oluwakemi Badaki-Makun*, J. Paul Scott, Julie A. Panepinto, T. Charles Casper, Cheryl A. Hillery, J. Michael Dean, David C. Brousseau, Elizabeth Powell, Robert Liem, Elizabeth Alpern, Kim Smith-Whitley, James Chamberlain, Lewis Hsu, Neil Hogg, Corrie Chumpitazi, Gladstone Airewele, Robert Hickey, Lakshmanan Krishnamurti, Julie Leonard, Monica HulbertNirupama Kannikeswaran, Sharada Sarnaik

*Corresponding author for this work

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso-occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso-occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi-center randomized double-blind placebo-controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesium's mechanism of action and the pathophysiology of VOC. Health-related quality of life was measured. Site-, protocol-, and patient-related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. Pediatr Blood Cancer 2014;61:1049-1054.

Original languageEnglish (US)
Pages (from-to)1049-1054
Number of pages6
JournalPediatric Blood and Cancer
Volume61
Issue number6
DOIs
StatePublished - Jan 1 2014

Fingerprint

Magnesium
Emergency Medical Services
Randomized Controlled Trials
Pediatrics
Hospital Emergency Service
Length of Stay
Research
Sickle Cell Anemia
Opioid Analgesics
Emergencies
Placebos
Quality of Life
Physicians
Safety
Neoplasms
Therapeutics

Keywords

  • Enrollment
  • Hematology
  • Hemoglobinopathies
  • Pain medicine
  • Randomized controlled trial
  • Sickle cell anemia
  • Sickle cell disease
  • Vaso-occlusive crisis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

Cite this

Badaki-Makun, O., Scott, J. P., Panepinto, J. A., Casper, T. C., Hillery, C. A., Dean, J. M., ... Sarnaik, S. (2014). Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: Methodological issues of a randomized controlled trial. Pediatric Blood and Cancer, 61(6), 1049-1054. https://doi.org/10.1002/pbc.24925
Badaki-Makun, Oluwakemi ; Scott, J. Paul ; Panepinto, Julie A. ; Casper, T. Charles ; Hillery, Cheryl A. ; Dean, J. Michael ; Brousseau, David C. ; Powell, Elizabeth ; Liem, Robert ; Alpern, Elizabeth ; Smith-Whitley, Kim ; Chamberlain, James ; Hsu, Lewis ; Hogg, Neil ; Chumpitazi, Corrie ; Airewele, Gladstone ; Hickey, Robert ; Krishnamurti, Lakshmanan ; Leonard, Julie ; Hulbert, Monica ; Kannikeswaran, Nirupama ; Sarnaik, Sharada. / Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis : Methodological issues of a randomized controlled trial. In: Pediatric Blood and Cancer. 2014 ; Vol. 61, No. 6. pp. 1049-1054.
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abstract = "Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso-occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso-occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi-center randomized double-blind placebo-controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesium's mechanism of action and the pathophysiology of VOC. Health-related quality of life was measured. Site-, protocol-, and patient-related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. Pediatr Blood Cancer 2014;61:1049-1054.",
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Badaki-Makun, O, Scott, JP, Panepinto, JA, Casper, TC, Hillery, CA, Dean, JM, Brousseau, DC, Powell, E, Liem, R, Alpern, E, Smith-Whitley, K, Chamberlain, J, Hsu, L, Hogg, N, Chumpitazi, C, Airewele, G, Hickey, R, Krishnamurti, L, Leonard, J, Hulbert, M, Kannikeswaran, N & Sarnaik, S 2014, 'Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: Methodological issues of a randomized controlled trial', Pediatric Blood and Cancer, vol. 61, no. 6, pp. 1049-1054. https://doi.org/10.1002/pbc.24925

Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis : Methodological issues of a randomized controlled trial. / Badaki-Makun, Oluwakemi; Scott, J. Paul; Panepinto, Julie A.; Casper, T. Charles; Hillery, Cheryl A.; Dean, J. Michael; Brousseau, David C.; Powell, Elizabeth; Liem, Robert; Alpern, Elizabeth; Smith-Whitley, Kim; Chamberlain, James; Hsu, Lewis; Hogg, Neil; Chumpitazi, Corrie; Airewele, Gladstone; Hickey, Robert; Krishnamurti, Lakshmanan; Leonard, Julie; Hulbert, Monica; Kannikeswaran, Nirupama; Sarnaik, Sharada.

In: Pediatric Blood and Cancer, Vol. 61, No. 6, 01.01.2014, p. 1049-1054.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis

T2 - Methodological issues of a randomized controlled trial

AU - Badaki-Makun, Oluwakemi

AU - Scott, J. Paul

AU - Panepinto, Julie A.

AU - Casper, T. Charles

AU - Hillery, Cheryl A.

AU - Dean, J. Michael

AU - Brousseau, David C.

AU - Powell, Elizabeth

AU - Liem, Robert

AU - Alpern, Elizabeth

AU - Smith-Whitley, Kim

AU - Chamberlain, James

AU - Hsu, Lewis

AU - Hogg, Neil

AU - Chumpitazi, Corrie

AU - Airewele, Gladstone

AU - Hickey, Robert

AU - Krishnamurti, Lakshmanan

AU - Leonard, Julie

AU - Hulbert, Monica

AU - Kannikeswaran, Nirupama

AU - Sarnaik, Sharada

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso-occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso-occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi-center randomized double-blind placebo-controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesium's mechanism of action and the pathophysiology of VOC. Health-related quality of life was measured. Site-, protocol-, and patient-related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. Pediatr Blood Cancer 2014;61:1049-1054.

AB - Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso-occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso-occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi-center randomized double-blind placebo-controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesium's mechanism of action and the pathophysiology of VOC. Health-related quality of life was measured. Site-, protocol-, and patient-related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. Pediatr Blood Cancer 2014;61:1049-1054.

KW - Enrollment

KW - Hematology

KW - Hemoglobinopathies

KW - Pain medicine

KW - Randomized controlled trial

KW - Sickle cell anemia

KW - Sickle cell disease

KW - Vaso-occlusive crisis

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