Timely Intravenous Magnesium for Asthma in Children (IMPACT-ED)
Asthma
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, IV Magnesium
Eligibility Criteria
Inclusion criteria are:
- A prior physician diagnosis of asthma confirmed by a treating physician in the ED who has spoken with the patient and family and reviewed the medical record (ED attending or fellow physician)
- Severe acute asthma, defined as a PRAM score of 8 or greater as assessed by a treating physician at the time of screening using the study scoring instrument, which takes 60 seconds to complete
- Children 2-17 years of age
Exclusion criteria are:
- Known pregnancy (by patient or parent report) or positive pregnancy test on females 12 years of age and older
- Age-adjusted hypotension at presentation using age-based Pediatric Advanced Life Support parameters (children >1 year to 10 years, SBP<(70 + 2 x age in years); >10 years, SBP < 90 mmHg)71
- Known severe renal impairment (by parent or patient report)
- Application of assisted ventilation before enrollment assessment (intubated, bi-level positive airway pressure, continuous positive airway pressure)
- Received IVMg within 24 hours prior to screening (by parent or patient report or medical record review)
- Enrollment assessment is 60 minutes after the start of ED treatment (start of first albuterol treatment)
- Previous enrollment in the same trial (by research coordinator review of trial records)
Sites / Locations
- Nationwide Children's Hospital
- Children's Hospital of Philadelphia
- Primary Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
75 mg/kg
50 mg/kg
Placebo
Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of IVMg from the commercial container using sterile technique and mixing in a polyvinylchloride container with a specified volume of sterile water. For the 75 mg/kg arm, this will be accomplished by mixing 37.5 mL of IVMg (80 mg/mL) with 2.5 mL of sterile water for a final concentration of 75 mg/mL and volume of 40 mL. After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.
Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of IVMg from the commercial container using sterile technique and mixing in a polyvinylchloride container with a specified volume of sterile water. For the 50 mg/kg arm, this will be accomplished by mixing 25 mL of IVMg (80 mg/mL) with 15 mL of sterile water for a final concentration of 50 mg/mL and volume of 40 mL. After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.
For the placebo arm, 40 mL of 0.9% sodium chloride solution will be drawn into a polyvinylchloride container identical in appearance to the containers used for the IVMg arms. After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.