Comparison of two medicines to help children stay calm and reduce pain during medical procedures

INTERVENTION: Intervention1: Dexmedetomidine Ketamine: In the intervention arm, dexmedetomidine 1 g/kg IV will be administered over 10 minutes, followed by ketamine 1 mg/kg IV immediately before the procedure. If adequate sedation is not achieved (RSS 4), rescue ketamine 0.5 mg/kg IV will be administered as required. If the cumulative ketamine dose exceeds 2 mg/kg and adequate sedation is still not achieved, an additional dose of dexmedetomidine 1 g/kg IV will be administered over 10 minutes. The maximum cumulative ketamine dose will be limited to 4 mg/kg. Intervention2: Dexmedetomidine Ketamine: In the intervention arm, dexmedetomidine 1 g/kg IV will be administered over 10 minutes, followed by ketamine 1 mg/kg IV before the procedure. If adequate sedation is not achieved (RSS 4), rescue ketamine 0.5 mg/kg IV will be administered as required. If the cumulative ketamine dose exceeds 2 mg/kg and adequate sedation is still not achieved, an additional dose of dexmedetomidine 1 g/kg IV will be administered over 10 minutes. The maximum cumulative ketamine dose will be limited to 4 mg/kg. Control Intervention1: Midazolam Ketamine: n the comparator arm, midazolam 0.1 mg/kg IV will be administered over 10 minutes, followed by ketamine 1 mg/kg IV immediately before the procedure. If adequate sedation is not achieved (RSS 4), rescue ketamine 0.5 mg/kg IV will be administered as required. If the cumulative ketamine dose exceeds 2 mg/kg and adequate sedation is still not achieved, an additional dose of midazolam 0.1 mg/kg IV will be administered over 10 minutes. The maximum cumulative ketamine dose will be limited to 4 mg/kg. Control Intervention2: Midazolam Ketamine: In the comparator arm, midazolam 0.1 mg/kg IV will be administered over 10 minutes, followed by ketamine 1 mg/kg IV before the procedure. If adequate sedation is not achieved (RSS 4), rescue ketamine 0.5 mg/kg IV will be administered as required. If the cumulative ketamine dose exceeds 2 mg/kg and adequate sedation is still not achieved, an additional dose of midazolam 0.1 mg/kg IV will be administered over 10 minutes. The maximum cumulative ketamine dose will be limited to 4 mg/kg. CONDITION: Health Condition 1: 3‐ Administration PRIMARY OUTCOME: To compare the recovery time in minutes, defined as the time interval from administration of the last dose of study drug or ketamine, whichever was administered later to attainment of a Modified Aldrete Recovery Score 8.Timepoint: Immediately after the procedure, at attainment of Modified Aldrete Recovery Score 8 INCLUSION CRITERIA: 1.Children aged 6 months to 18 years requiring procedural sedation for painful bedside procedures 2.ASA classification status I, II and III SECONDARY OUTCOME: 1.Time to achieve adequate sedation. ; 2.Sedation time. ; 3.Requirement for rescue ketamine administration. ; 4.Incidence of respiratory adverse events, including oxygen desaturation, apnea, partial upper airway obstruction, complete upper airway obstruction, & clinically apparent pulmonary aspiration. ; 5.Incidence of cardiovascular adverse events bradycardia & hypotension. ; 6.Incidence of gastrointestinal adverse events nausea, vomiting. ; 7.Incidence of neurologic & behavioural adverse events, including excitatory movements & unpleasant recovery reactions. ; Timepoint: Immediately after study drug administration, till attainment of Modified Aldrete Recovery Score 8