Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from October 2006 through June 2008 at 10 sites across the United States. Due to the acute nature of the disease under study, subjects were recruited in a hospital, frequently in the Emergency Department.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No events excluded patients following enrollment, but prior to group assignment. Group assignments were made at enrollment.

Reporting Groups

	Description
Dexamethasone	0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
Placebo	0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).

Participant Flow:   Overall Study

	Dexamethasone	Placebo
STARTED	6	6
COMPLETED	5	6
NOT COMPLETED	1	0
Protocol Violation	1	0

Reporting Groups

	Description
Dexamethasone	0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
Placebo	0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).

Baseline Measures

	Dexamethasone	Placebo	Total
Number of Participants   [units: participants]	6	6	12
Age   [units: participants]
<=18 years	4	5	9
Between 18 and 65 years	2	1	3
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	18.8  ± 14.08	15.8  ± 12.81	17.3  ± 12.93
Gender   [units: participants]
Female	2	3	5
Male	4	3	7
Region of Enrollment   [units: participants]
United States	6	6	12

1.  Primary:

Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less   [ Time Frame: Measured from first dose to end of the hospital stay, no maximum number of days ]

2.  Secondary:

Rating of Pain   [ Time Frame: Measured at the end of the hospital stay ]

3.  Secondary:

Duration of Hospitalization   [ Time Frame: Measured at the end of hospital stay, no maximum number of days ]

4.  Secondary:

Duration of Supplemental Oxygen   [ Time Frame: Measured at the end of hospital stay ]

5.  Secondary:

Duration of Hypoxemia (Low Blood Oxygen)   [ Time Frame: Measured at the end of hospital stay ]