Ketamine dose finding study in pediatric burn wound care

INTERVENTION: Product Name: Ketamine Pharmaceutical Form: Intravesical solution/solution for injection INN or Proposed INN: KETAMINE HYDROCHLORIDE CAS Number: 1867‐66‐9 Current Sponsor code: N/A Other descriptive name: KETAMINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ CONDITION: Pediatric burn patients who need rectal sedation during wound care Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: The objective of this study is to compare the effects of three different doses of rectally administrated Ketamine in pediatric burn wound care Primary end point(s): The primary endpoint is pain/anxiety; ; Secondary variables are the presence of side effects, recovery time, acceptance of treatment and sedation level.; ; Safety variables are saturation, respiratory and heart rate, blood pressure and documentation of AE and SAE reporting. What is considered an AE is defined in the study protocol Secondary Objective: not applicable Timepoint(s) of evaluation of this end point: Primary endpoint; Before, during and after sedation/wound care. ; ; SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints; during and after sedation ; ; Timepoint(s) of evaluation of this end point: Safety variables (vital signs) are evaluted every fifth minute. INCLUSION CRITERIA: • Children aged 0.5‐4 years and weighing over 7 kg and below 38 kg. • Burns requiring sedation at least three occasions after written consent could be obtained. • Written consent from the child's guardian or legal representative • Swedish‐speaking parents alt. interpreter on site • Fasting from food at least 6 hours, breast milk 4 hours and clear liquids 2 hours before initiation of sedation Are the trial subjects under 18? yes Number of subjects for this age range: 60 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 this age range