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IRCT20220120053770N1 IRCT 2022-02-12 Tehran University of Medical Sciences Evaluation of the effectiveness of low-dose ketamine (Sub dissociative) with dexmedetomidine in controlling pain in patients with limb trauma referred to emergency department Evaluation of the efficacy of low-dose (sub dissociative) ketamine with dexmedetomidine, and its comparison with morphine in controlling pain in patients with limb trauma referred to emergency department of Sina hospital 2022-04-03 anticipated 258 Complete https://irct.ir/trial/61417 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients have already been randomly divided into two categories by a statistician using Block Stratified Randomization Windows version 6.0 software, and their randomization list has been provided to the researcher. Each day five participants from those two groups will be involved and they will be ordered randomly . Every morning a person not involved in the study or patient care prepared study packages and stored them in a locked drawer. When each new subject was enrolled by an attending emergency physician, they were allocated to the next number based on the randomization schedule. The physician then picked up the matched, numbered package from the drawer, Blinding description: In this study, the patient does not know the type of drug used. Also, to observe the principle of blinding in the study, the researcher and the person who follows and records the patient's pain are two different people, ie one person enters the patient and follows and another person selects and prescribes the patient's medication. The person following the patient will not be aware of the medication the patient has taken. 3 Pain management of limb trauma in emergency department. Intervention 1: Intervention group: Intravenous ketamine with sub dissociative dose (0.3 mg / kg) with intravenous dexmedetomidine (1 mcg / kg). Intervention 2: Intervention group: Intravenous morphine (0.1 mg / kg). Yes - There is a plan to make this available What will be shared: All collected data will be available When: 6 months after publication To whom: Data will be available for Academic researchers and scientists Conditions: Statistical analysis of data Where to obtain: contact mmatininmoradi@yahoo.com How to obtain: After receiving the application, the requested information will be provided within one month Comments:
public Alireza Baratloo
Sina Hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 arbaratloo@sina.tums.ac.ir Tehran University of Medical Sciences scientific Alireza Jalali
Sina Hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 a.jalall85@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Adult patients (older than 18 years old) gave pain more than five points limb trauma pain obtaining the informed consent 18 years no limit Both Pain score ≤5 Pregnancy and post-partum women Altered mental status Allergy to ketamine or fentanyl Body weight ≤ 46 kg or ≥ 115 Unstable vital signs: BP≤ 90 mmHg or ≥ 180 mmHg , PR≥150 or ≤50 bits/min , RR≤10 or ≥30 History of recent head or eye trauma History of Siesure History of elevated ICP Chronic pain Renal or hepatic failure Substance or alcohol abuse Documented psychiatric disorders Opium addiction Recent use of narcotic analgesics G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Intervention group: Intravenous ketamine with sub dissociative dose (0.3 mg / kg) with intravenous dexmedetomidine (1 mcg / kg) Intervention group: Intravenous morphine (0.1 mg / kg) Pain numerical rating scale. Timepoint: Intervals of 5, 10, 15, 30 minutes. Method of measurement: requires the patient to rate their pain (0–10) where 0 is no pain and 10 is the worst pain imaginable. Tehran University of Medical Sciences Approved 2022-01-17 Research Ethics Committees of Sina Hospital Sina Hospital Tehran Tehran Iran (Islamic Republic of)