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IRCT201212312496N8 IRCT 2013-01-03 Research Vice chancellor of Tabriz University of Medical Sciences Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department 2013-01-20 anticipated 80 Complete https://irct.ir/trial/2225 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 1-2 sedation during procedure. Intervention 1: Oral Diphenhydramin : 0.5mg/kg. Intervention 2: Oral ketamin(6mg/kg), Midazolam(0.05mg/kg) and Atropine(0.02mg/kg) cocktail.
public Dr.Hassan Soleimanpour
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
Tabriz Iran (Islamic Republic of) 51664 +98 41 1335 2078 h_mofid1357@yahoo.com Tabriz University of Medical Sciences scientific Dr.Hassan Soleimanpour
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664 Iran (Islamic Republic of) 51664 +98 41 1335 2078 h_mofid1357@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Children aged 2-10 years having referred to the emergency department for wound stitches requiring local anesthesia prior to the procedure. Exclusion criteria: Patients with the history of psychologic or mental disorders, children with attention deficit-hyperactivity disorder, multiple traumas, GCS<15, common cold, unwillingness of the parents to take part in the study, illiterate parents, known allergy, prior history of erythromycin administration, chronic underlying diseases such as convulsive disorders, patients with lower-extremity ulcers, mucosal ulcers, wounds larger than 4 centimeters or with the depth of more than 0.5 centimeters and single ulcers, too. 2 years 10 years Both T88.52 sedation(conscious) (moderate) during procedure Prevention Prevention Oral Diphenhydramin : 0.5mg/kg Oral ketamin(6mg/kg), Midazolam(0.05mg/kg) and Atropine(0.02mg/kg) cocktail Sedation. Timepoint: Every 5 minutes to 45 minutes after administration of sedatives. Method of measurement: Grade 1: drowsiness, the patient needs a stimulus for waking up- Grade 2: drowsiness, the eyes are closed and patient needs a mild verbal or touch stimulus for waking up- Grade 3: drowsiness, the eyes are open but the eye responsiveness has reduced to low activity- Grade 4: complete awakeness- Grade 5: complete agitation. All behavioral patterns of the child including cry, consciousness, and movement throughout the procedure. Timepoint: When local anesthetic injecting and during the procedure. Method of measurement: Based on the Houpt scale. Research Vice chancellor of Tabriz University of Medical Sciences Approved 2012-06-25 Research Vice chancellor of Tabriz University of Medical Sciences Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz Iran (Islamic Republic of)