]>
IRCT20200809048341N1 IRCT 2020-11-23 Yazd University of Medical Sciences Comparison of ketamine /propofol Versus ketamine/Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation Comparison of ketamine /propofol Versus ketamine/Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation 2020-11-28 anticipated 90 Complete https://irct.ir/trial/50629 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization: Based on a random sequence of numbers from Random.org, a table will be prepared, with the first forty-five consecutive numbers in Group A and the next forty-five consecutive numbers in Group B.These numbers will be assigned to each patient in order of referral, Blinding description: The person performing the reduction and the patient themselves do not know the type of medicine; For this purpose, the syringe containing the drug is covered in such a way that the color of the drug is not clear. 3 Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation. Intervention 1: Intervention group 1: First, we inject 30 mg of ketorolac intravenously in all patients for 30 minutes 15 minutes before prescribing other drugs. We then inject 1 mg of midazolam intravenously into all patients. Then from the combination of ketamine / propofol (ketamine 1 mg per kg body weight (maximum 50 mg) and propofol 1 mg per kg body weight (maximum 50 mg) intravenously and slowly for 30-60 seconds) Used. If sedation does not occur in this group within 3 minutes, half the dose of the first medication is repeated. If, after injecting the initial dose, after receiving two and a half doses of the drug, proper sedation does not occur or the reduction is not successful, sedation is considered a failure and orthopedic consultation is requested. Appropriate sedation is determined by the RASS score (Richmond Agitation and Sedation Scale); We start reduction when the patient has a RASS score of -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of ondansetron at a dose of 4 mg and in case of hypoxia, apnea or spasm, respectively, head tilt chin lift, oral airway and ambobag breathing, and if none of them were effective, intubation should be used. Intervention 2: Intervention group 2: First, all patients are injected with 30 mg of intravenous ketorolac within 30 seconds 15 minutes before prescribing other drugs. One mg of midazolam is then injected intravenously into all patients. The thiopental / ketamine combination is then used (ketamine 1 mg per kg body weight (maximum 50 mg) and thiopental 2 mg per kg body weight (maximum 100 mg) intravenously and slowly Within 30-60 seconds). If sedation does not occur in this group within 3 minutes, half the dose of the first medication is repeated. If proper sedation does not occur after injecting the initial dose after receiving two half doses, or the reduction is not successful, failure in sedation is considered and orthopedic consultation is requested. Appropriate sedation is determined by the RASS score (Richmond Agitation and Sedation Scale)؛ We start reduction when the patient has a RASS score to -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of ondansetron at a dose of 4 mg and in case of hypoxia, apnea or , spasm, respectively, head tilt chin lift, oral airway and ambobag breathing, and if none of them were effective, intubation should be used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Zahra Hajisafari Tafti
No. 9, Shamshad Alley 7, Fatemieh Blvd, Shahid Sadoughi Town
Taft Iran (Islamic Republic of) 8991877685 +98 35 3263 5841 Z.hajisafaritafti@gmail.com Yazd University of Medical Sciences scientific Soheila Azimi Aabarghouei
Emergency ward, Shahid Sadoughi Hospital, Ebne sina Blvd.
Yazd Iran (Islamic Republic of) 8913893111 +98 35 3828 2682 S.azimi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Healthy patients without previous disease and those with mild systemic disease without functional limitations according to the American Society of Anesthesiologist classification (individuals 1 and 2) Those who have been NPOs ( Nil Per Os) or consumed fluids in the last 3 hours Those that do not need to be reduced in the operating room. Age 18 to 64 years 18 years 64 years Both Any contraindications including asthma and COPD(chronic obstructive pulmonary disease), systolic blood pressure below 90 or above 180, ischemic heart disease or heart failure, any symptoms in favor of increased intracranial pressure, glaucoma, psychosis and use of any psychotropic substances, acute or chronic alcoholism, liver or kidney failure, Allergies to any of the drugs studied or eggs or soy, people addicted to drugs, taking any sedatives or anesthetics before going to the emergency room, obstructive sleep apnea syndrome, maxillofacial malformations that block the airway, Pregnancy, dislocations lasting more than 24 hours, multiple trauma or hemodynamic instability, history of uncontrollable seizures, and patients who do not wish to participate in the study S43.0 Subluxation and dislocation of shoulder joint Treatment - Drugs Treatment - Drugs Intervention group 1: First, we inject 30 mg of ketorolac intravenously in all patients for 30 minutes 15 minutes before prescribing other drugs. We then inject 1 mg of midazolam intravenously into all patients. Then from the combination of ketamine / propofol (ketamine 1 mg per kg body weight (maximum 50 mg) and propofol 1 mg per kg body weight (maximum 50 mg) intravenously and slowly for 30-60 seconds) Used. If sedation does not occur in this group within 3 minutes, half the dose of the first medication is repeated. If, after injecting the initial dose, after receiving two and a half doses of the drug, proper sedation does not occur or the reduction is not successful, sedation is considered a failure and orthopedic consultation is requested. Appropriate sedation is determined by the RASS score (Richmond Agitation and Sedation Scale); We start reduction when the patient has a RASS score of -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of ondansetron at a dose of 4 mg and in case of hypoxia, apnea or spasm, respectively, head tilt chin lift, oral airway and ambobag breathing, and if none of them were effective, intubation should be used. Intervention group 2: First, all patients are injected with 30 mg of intravenous ketorolac within 30 seconds 15 minutes before prescribing other drugs. One mg of midazolam is then injected intravenously into all patients. The thiopental / ketamine combination is then used (ketamine 1 mg per kg body weight (maximum 50 mg) and thiopental 2 mg per kg body weight (maximum 100 mg) intravenously and slowly Within 30-60 seconds). If sedation does not occur in this group within 3 minutes, half the dose of the first medication is repeated. If proper sedation does not occur after injecting the initial dose after receiving two half doses, or the reduction is not successful, failure in sedation is considered and orthopedic consultation is requested. Appropriate sedation is determined by the RASS score (Richmond Agitation and Sedation Scale)؛ We start reduction when the patient has a RASS score to -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of ondansetron at a dose of 4 mg and in case of hypoxia, apnea or , spasm, respectively, head tilt chin lift, oral airway and ambobag breathing, and if none of them were effective, intubation should be used. Time to appropriate sedation. Timepoint: 3 minutes after the last drug injection. Method of measurement: physical examination. The duration of the effect of the drug. Timepoint: 15 minutes after drug injection. Method of measurement: Physical examination. Discharge time. Timepoint: 15 minutes after drug infection. Method of measurement: Physical examination. The pain before reduction. Timepoint: before starting reduction. Method of measurement: By the visual analog scale. Need to additional doses of medication. Timepoint: 3 minutes after the last injection. Method of measurement: Physical examination. Incidence of any side effects. Timepoint: Before injecting the drug and every 5 minutes. Method of measurement: Physical examination and vital signs. Pain during reduction. Timepoint: During reduction. Method of measurement: By the facial pain scale. Yazd University of Medical Sciences Approved 2020-05-12 Ethics committee of School of Medicine _ Shahid Sadoughi University of Medical Sciences Central building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)