A comparative clinical study of sedative effects of intravenous and intramuscular Ketamin in pediatric patients
Phase 2
- Conditions
- Anesthesia.Dissociative anesthesia
- Registration Number
- IRCT2014071218454N1
- Lead Sponsor
- Vice chancellor for research, Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
INCLUSION CRITERIA: Age three months to 15 years and had to undergo short and painful emergency procedures. EXCLUSION CRITERIA: Subjects with a history of allergy to Ketamine; severe cardiovascular diseases; thyroid disorder; head injury; CNS disorders; glaucoma or acute globe injuries; and history or evidence of psychosis; obstructive sleep apnea; active pulmonary disease; tracheal stenosis or surgery; children needing procedures associated with stimulation of posterior pharyngeal region and not willing to participate
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation efficacy. Timepoint: During intervention. Method of measurement: Efficacy of medicine in pain management and sedation as excellent (full sedation, immobility, and analgesia during the whole procedure), moderate (slight movements due to pain without interfering to procedure), and poor (movements associated with pain that interfered in the procedure).;Respiratory Adverse Events. Timepoint: During intervention. Method of measurement: The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of administration of the drug until hospital discharge.;Procedure time. Timepoint: During intervention. Method of measurement: From the begining of sedatiion till emergency discharge.
- Secondary Outcome Measures
Name Time Method on respiratory adverse events. Timepoint: During intervention. Method of measurement: Dysphoria, Vomiting, Myoclonus, Nausea, Stiffness, Rash, Seizures, Restlessness.