- 62 patients, aged 5-17 years, experiencing exacerbation
of mild to moderate asthma were randomized in a double-blinded fashion
to receive a single dose of 2.5 mg of albuterol mixed with 2.5 cc of
normal saline or mixed with 2.5 cc of isotonic magnesium sulfate.1
- Patients were excluded if they had a temperature
>39 degrees C, history of chronic diseases such as BPD or CF, or
had received steroids or ipratropium in the past 3 days.
- The two groups were similar with respect to
age, sex, race, height, weight, temperature, presence and duration of
DIB and wheezing, HR, RR, pulse ox, and baseline FEV1.
- Patients in both groups received 2 mg/kg of
prednisone after the administration of the study drug and continued
to be treated equally with respect to the use of albuterol and other
- Assuming a mean difference of 15% in FEV1 as
significant, the study with the given sample size had a power greater
than 80% to yield a statistically significant result.
- FEV1 was measured initially and then 10 and
20 minutes following the administration of the study drug.
- At 10 minutes, the mean FEV1 was 1.41 L in the
albuterol + magnesium group as compared to 1.13 L in the albuterol +
saline group (p=0.03). At 20 minutes, this difference persisted, although
was not quite statistically significant (p=0.06).
- The difference in FEV1 as measured in % predicted,
was not significant between the two groups, although at 10 minutes,
the albuterol + magnesium group FEV1 was 74.6% as compared to 63.5%
in the albuterol + saline group with a p value of 0.07.
- In comparing FEV1 at 0, 10, and 20 minutes,
the differences within each group were significant between 0 and 10
minutes and 0 and 20 minutes but not between 10 and 20 minutes, leading
the authors to conclude that the effect of the study drugs occurred
primarily in the first 10 minutes.
- Two of the 31 patients in the magnesium group
and 1 of the 31 in the saline group required admission to the hospital.
None of the participants showed any side effects from the medications.