Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol loading dose | Experimental | Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg. |
|
| Sodium Chloride 0.9% | Placebo Comparator | 10 ml of Sodium Chloride 0.9% in 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol | Drug | Intravenous Salbutamol loading dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction Asthma score | The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour after administration of loading dose in the intervention group compared to the placebo group. Based on expert opinion, we consider a reduction of 2 points to represent a clinically relevant improvement. | First 24 hours after admission on the PICU |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative dose of IV salbutamol | Through study completion, an average 48 hours | |
| Maximum infusion rate of IV salbutamol in mcg/kg/min | Through study completion, an average 48 hours | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3000WB | Netherlands |
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Chloride 0.9% |
| Drug |
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous |
|
| Total duration of IV salbutamol treatment in hours |
| Through study completion, an average 48 hours |
| Occurrence/frequency of side effects | Through study completion, an average 48 hours |
| Length of Stay on PICU in days | Through study completion, an average 72 hours |
| Use of co-medication | Through study completion, an average 72 hours |
| Use of/duration of non-invasive mechanical ventilation in days | Through study completion, an average 72 hours |
| DNA polymorphism of the ADRB2-receptor gene | The investigators will look at DNA, if there is a polymorphism in the ADRB2-receptor gene. If there is a polymorphism it can cause downregulation of the adrenergic B2 receptors. | Through study completion, an average 1 year |
| Use of/duration of non-invasive/invasive mechanical ventilation in days | Through study completion, an average 72 hours |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |