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

Determination of the effectiveness of low-dose ketamine with dexmedetomidine, and its comparison with morphine in controlling pain in patients with limb trauma referred to the emergency department

Clinical trial, with a parallel-group, double-blind, randomized, phase 3 on 258 patients. Using Block Stratified Randomization software, Windows version 6.0 is randomly divided into two categories.

258 adult patients who were referred to the emergency department with pain due to limb trauma are randomly divided into two groups. After obtaining informed consent to participate in the study, they receive the drugs, then by comparing the scores they have suffered before and after taking the drug (at intervals of 5, 10, and 15 minutes after injecting the drug) and We will also discuss the possible benefits of this alternative method for its side effects.

Adult patients who have been referred to the Sina Hospital emergency department with limb trauma. Patients with the following characteristics will not be included in the study 1. Pain score ≤ 5, 2. Pregnancy and post-partum women, 3. Altered mental status, 4. Allergy to ketamine or morphine or dexmedetomidine, 5. Bodyweight ≤ 46 kg or ≥ 115, 6. Unstable vital signs: BP≤ 90 mmHg or ۸ 180 mmHg, PR≥150 or ≤50 bits/min, RR≤10 or ≥30, 7. History of the recent head or eye trauma, 8. History of seizure, 9. History of elevated ICP, 10. Chronic pain, ۱۱. Renal or hepatic failure, 12. Substance or alcohol abuse, 13. Documented psychiatric disorders, 14. Opium addiction, 15. Recent use of narcotic analgesics

Two groups of intravenous sub dissociative ketamine (0.3 mg/kg) with (1 mcg/kg) intravenous dexmedetomidine or intravenous morphine (0.1 mg/kg).

Pain intensity; blood pressure; heartbeat; Number of breaths; drug side effects; rescue analgesia

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.

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.

All collected data will be available

6 months after publication

Data will be available for Academic researchers and scientists

Statistical analysis of data

contact mmatininmoradi@yahoo.com

After receiving the application, the requested information will be provided within one month