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IRCT2014071218454N1 IRCT 2014-12-30 Vice chancellor for research, Mashhad University of Medical Sciences A comparative clinical study of sedative effects of intravenous and intramuscular Ketamin in pediatric patients Comparison of sedation with intravenous and intramuscular Ketamin in children admitted to the emergency department: a Randomized Controlled Trial 2014-03-22 anticipated 240 Complete https://irct.ir/trial/16733 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Anesthesia. Intervention 1: Patients in control group will recieve Ketamine 1.5 ml / kg before procedures via intravenous infusion. Intervention 2: In the intervention group the patients will receive intera muscular Ketamine at a dose of 4 ml / kg once before procedures.
public Behnaz Borouman Rezazade
Emam Reza Hospital, Emam Reza square, Avicina avenue, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) +98 51 3852 5312 dr.boroumand@hotmail.com Mashhad University of Medical Sciences scientific Hamid Zamani Moghadam
Emam Reza Hospital, Emam Reza square, Avicina avenue, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) +98 51 3852 5312 zamanimh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 3 months 15 years Both F44.6 Dissociative anesthesia Treatment - Drugs Treatment - Drugs Patients in control group will recieve Ketamine 1.5 ml / kg before procedures via intravenous infusion In the intervention group the patients will receive intera muscular Ketamine at a dose of 4 ml / kg once before procedures 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. Non respiratory adverse events. Timepoint: During intervention. Method of measurement: Dysphoria, Vomiting, Myoclonus, Nausea, Stiffness, Rash, Seizures, Restlessness. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2013-05-18 Mashhad University of Medical Sciences Ethics Committee Vice chancellor for research Mashhad Univercity of Medical Sciences, Ghoreishi building, Daneshgah avenue, Mashhad, Iran. Mashhad Iran (Islamic Republic of)