PILOT RANDOMISED CONTROLLED TRIAL USIDNG DEXAMETHASONE VESUS PREDNISOLONA/PREDNISONA IN CHILDREN WITH ACUTE ASTHMA IN PEDIATRIC EMERGENCY WARD

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2013
INTERVENTION: Trade Name: Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital Product Name: DEXAMETHASONE Product Code: DEXAMETHASONE Pharmaceutical Form: Oral suspension INN or Proposed INN: DEXAMETHASONE CAS Number: 50‐02‐2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital Product Name: PREDNISOLONA Product Code: PREDNISOLONA Pharmaceutical Form: Oral suspension INN or Proposed INN: PREDNISOLONE CAS Number: 8056‐11‐9 Other descriptive name: PREDNISOLONE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 13‐ Trade Name: Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital Product Name: PREDNISONA Product Code: PREDNINSONA Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONA CAS Number: 53‐03‐2 Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ CONDITION: ASTHMA ; MedDRA version: 14.1 Level: PT Classification code 10049585 Term: Infantile asthma System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: Determine whether administration of 2 doses of oral dexamethasone is as effective or more effective than the administration of prednisolone 5 days / oral prednisone in the improvement of symptoms of asthma Primary end point(s): Percentage of children with persistent symptoms at 7 days after hospital discharge with oral steroid therapy (dexamethasone versus prednisone / prednisolone) following an acute asthma attack. Secondary Objective: Determine whether the administration of 2 doses of oral dexamethasone is more effective or as effective as 5‐day administration of prednisolone / oral prednisone in the prevention of relapse and re‐visits to the emergency room.; To assess the safety and tolerability of the treatment given in this context. Timepoint(s) of evaluation of this end point: During the participation of the child in the trial (7 days) SECONDARY OUTCOME: Secondary end point(s): Percentage of children requiring hospitalization after their stay in the observation unit; Percentage of patients requiring a stay in the observation unit before discharge to home; Percentage of children who require hospitalization after a revisit; Adherence to treatment with oral corticosteroids; Percentage of children who have episodes of vomiting during oral corticosteroid treatment; Satisfaction of parents with corticosteroid treatment assigned to their children; Revisit to the emergency room or your primary care pediatrician at 7 and 15 days after discharge to home; Truancy days from the onset of the acute episode until the incorporation of the child to school; Absenteeism days of the mother, father and / or guardian from the beginning of the acute episode to recovery of child Timepoint(s) of evaluation of this end point: During the participation of the child in the trial (15 days) INCLUSION CRITERIA: Children admitted SUP aged 1 to 16 years. With acute asthma: any child with respiratory symptoms (cough, shortness of breath, tachypnea) attributed to bronchospasm (wheezing, prolonged expiration, hypoventilation, etc ...), regardless of the possible trigger (infection, mites, pollen, etc ...) or the presence or absence of previous episodes. Children after initial treatment with salbutamol (1 dose) did not exhibit clinical improvement and require treatment with systemic corticosteroids. He has informed the patient and their parents / guardians have been given sufficient time and opportunity to consider their participation and have given consent. Subject is willing and able to meet all the requirements of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 1000 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for th
Epistemonikos ID: f4cb26598f1ab97f3ab0c963c26c0bb5be2006e8
First added on: Aug 22, 2024