]>
IRCT20130108012072N13 IRCT 2022-08-30 Esfahan University of Medical Sciences Ketodex Efficacy for adult procedural sedation Ketamine-Dexmedetomidine (Ketodex) versus Ketamine and ketofol for adult procedural sedation in Emergency Department 2022-09-23 anticipated 135 Complete https://irct.ir/trial/64646 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers. In this study, based on predefined 3-digit number (001,002,003,...) randomization table, blindly choose one number, then upper and below numbers choose vertically as treatment code for each patient. ٍAfter ending the the numbers, manager blindly choose another number again and apply the upper and below numbers for each patient. Every 3-digit number from 001 to 105, marked as one randomized treatment protocol (45 number for treatment protocol "A", 45 number for treatment protocol "B" and 45 number for treatment protocol "C"); study manager doesn't knowing about drug that use in each protocol. Chosen numbers must be lesser than sample size and greater numbers will be deleted. This protocol continued until all patients who meet inclusion criteria get a random number. Due to this method, patients stay on one treatment group, without knowing about treatment protocol, Blinding description: Drugs are preparing with scientist and labeled (scientist is blinded to patient's treatment group and efficacy or complications of each groups). Patients are selected with randomized numeric table and don't aware about treatment protocol. Manager use treatment pathway base on patient randomization; blinded about drug that be used and record result and complications. Statistical analyst, analyses the study without knowing about patients group and give the results to researcher for conclusion. 3 Adult procedural sedation. Intervention 1: Intervention group 1: 1 mg/kg diluted Ketamine in 20 ml normal saline. Intervention 2: Intervention group 2: 0.5 mg/kg diluted Ketofol in 20 ml normal saline. Intervention 3: Intervention group 3: 1 mg/kg diluted Ketamine and 0.7 microgram/kg Dexmedetomidine in 20 ml normal saline. Yes - There is a plan to make this available What will be shared: Whole of data after coding When: Accessibility after 2023 To whom: Everyone Conditions: For seemingly studies data released to academic chairman's Where to obtain: Isfahan University of Medical Sciences How to obtain: Emailing to m_esmailian@med.mui.ac.ir Comments:
public Mehrdad Esmailian
Hezarjerib Av., Isfahan
Isfahan Iran (Islamic Republic of) 8175898595 +98 31 3629 3482 m_esmailian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Esmailian
Hezarjerib Av., Isfahan
Isfahan Iran (Islamic Republic of) 8175898595 +98 31 3629 3482 m_esmailian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with pain severity status of Anesthesiology physical status I to III (ASA I-III), Visual Analog Scale>4 18 years no limit Both َAddiction to drugs and analgesics Use of analgesics in 24 hours ego Underlying disease such as hypertension, liver and kidney disease) Pregnancy Psychiatric disease such as psychosis Severe verbal or hearing disability Sensitivity to Ketamine, Ketofol and Ketodex Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 1 mg/kg diluted Ketamine in 20 ml normal saline Intervention group 2: 0.5 mg/kg diluted Ketofol in 20 ml normal saline Intervention group 3: 1 mg/kg diluted Ketamine and 0.7 microgram/kg Dexmedetomidine in 20 ml normal saline Pain severity score with Visual Analog Scale. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Visual Analog Scale. Sedation level with Ramsay Sedation Score (RASS). Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Ramsay Sedation Score (RASS). Hemodynamic changes. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Manometer; Heart rate; Pulseoximetry. Agitation. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Checklist. Esfahan University of Medical Sciences Approved 2022-08-27 Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjerib Ave., Azadi square, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)