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IRCT20171211037834N2 IRCT 2019-11-25 Esfahan University of Medical Sciences Comparison effect of submucosal injection and intravenous injection of ketamine on conscious sedation Comparison effect of submucosal injection and intravenous injection of ketamine on conscious sedation in patients who need wound repair in emergency department 2019-09-23 anticipated 184 Complete https://irct.ir/trial/42243 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple individualized randomization with random allocation software. 2-3 sedation depth by ketamin in wound repair. Intervention 1: Control group: 1.5 mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe intravenously. Intervention 2: Intervention group: 2mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe submocousally. Intervention 3: Intervention group: 3mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe submocousally. Intervention 4: Intervention group: 4mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe submocousally. Yes - There is a plan to make this available What will be shared: all of data will be Shareable after unrecognizable patients. When: data will be available 1 year after release. To whom: data will be available just for research centers of universities. Conditions: analysis is permitted and special condition is not considered. Where to obtain: availability request should be send via email with Introduction letter from research center. How to obtain: after request email received, an email for identity confirmation will be sent to research center.In case of confirmation, data will be send via email. Comments:
public Mahdi Ahmadpour
Unit 411, Mahtab Residential Complex, Ghadir Blvd, Sepahan Shahr
Isfahan Iran (Islamic Republic of) 8179949841 +98 31 3651 5338 dr.ahmadpour.ma@gmail.com Esfahan University of Medical Sciences scientific Mahdi Ahmadpour
Unit 411, Mahtab Residential Complex, Ghadir Blvd, Sepahan Shahr
Isfahan Iran (Islamic Republic of) 8179949841 +98 31 3651 5338 dr.ahmadpour.ma@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) children who are candidates for wound repair patients without IV line before emergency department enterance parents informed consent for study participation 2-8 years old 2 years 8 years Both ketamin sensitivity physical or mental disability immune systme diseases another necessity for IV line fixation for patient hypertension recent seziures thyroid diseases glaucoma or acute globe injury psychopathy history of airway instability and tracheal stenosis major procedures that cause posterior nasopharyngeal stimulation active lung and upper airway infection cardiovascular disease such as cardiac failure and angina pectoris porphyria major head trauma, CNS tumor, hydrocephalus Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: 1.5 mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe intravenously Intervention group: 2mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe submocousally Intervention group: 3mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe submocousally Intervention group: 4mg/kg ketamin, rotexmedica Germany company production and with 28 gauge syringe submocousally Sedation depth average. Timepoint: during procedure. Method of measurement: Ramsey score. Frequency distribution of doctors satisfaction. Timepoint: after procedure. Method of measurement: very bad(0), bad(1), usual(2), good(3), very good(4). Systolic blood pressure average. Timepoint: before, during, 5-10-15-30 min after injection. Method of measurement: Sphygmomanometer. Heart rate average. Timepoint: before, during, 5,10,15,30 min after injection. Method of measurement: cardiac monitor. O2 saturation percent average. Timepoint: before, during, 5-10-15-30 min after injection. Method of measurement: pulse oximetry. Respiratory rate average. Timepoint: before, during, 5-10-15-30 min after injection. Method of measurement: respiration in 1 minute. Admition duration average. Timepoint: during discharge. Method of measurement: admition duration in minute. Sedation duration average. Timepoint: during sedation. Method of measurement: since the patient dose not obey orders until the patient obeys orders again. Sedation onset average. Timepoint: drug administration. Method of measurement: from drug administration to disobedience onset. Esfahan University of Medical Sciences Approved 2017-02-22 Ethics committee of Isfahan University of Medical Sciences hezarjirib Avenue Isfahan Isfehan Iran (Islamic Republic of)