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IRCT20200608047684N1 IRCT 2020-07-30 Tehran University of Medical Sciences Efficacy of Ketamine on Acute Pain Comparing the Efficacy of Fentanyl Versus Subdissociative-dose Ketamine with Haloperidol on Acute Pain in Adult Patients 2020-07-31 anticipated 200 Complete https://irct.ir/trial/48723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants divided in two groups randomly by a statistics specialist with Block Stratified Randomization Windows version 6.0. Each day five participants from those two groups will involved and they will be ordered randomlly .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 randomizationschedule. The physician then picked up the matched, numbered package from the drawer, Blinding description: In this research participants aren't informed about the adiministrated medication.Due to the similar appearance of the drugs, the syringes are not covered and according to the information given to the patient, distilled water will be injected instead of haloperidol for patients in the control group (fentanyl). Regarding the side effects described to the patient in informed consent, no information was given about the potential for pain relief of the drugs. For blinding, researcher who chooses patients to participate in research, person who administrates the medications and observer who observes and documents participant's pain are separated persons. 3 Acute pain. Intervention 1: Intervention group: patients with acute pain that treated with 0.3 mg/kg interavenous Ketamine and 2.5 mg interavenous Haloperidol. 2.5 mg Haloperidol diluted with distilled water up to 5ml will be injected by 5ml syringe in one minute through IV line .then immediately the calculated dosage of Ketamine will be diluted by distilled water up to 10ml and will be injected by 10ml syringe in two minutes through same IV line. Intervention 2: Intervention group: patients with acute pain that treated with 1 μg/kg interavenous Fentanyl. In this group first 5ml distilled water will be injected through IV line in one minute insted of Haloperidol then the calculated amount of Fentanyl will be diluted with distilled water up to 10ml and will be injected by 10ml syringe in two minutes through IV line. Yes - There is a plan to make this available What will be shared: All collected data will be available When: 6 months afer publication To whom: Data will be available for Academic researchers and scientists Conditions: Statistical analysis of data Where to obtain: contact M.mobin.moradi@gmail.com How to obtain: After receiving the application, the requested information will be provided within one month Comments:
public Mohammad Mobin Moradi
No 63, Saduqi Ave, Jamalzadeh St
Tehran Iran (Islamic Republic of) ۱۴۱۸۶۱۳۷۴۱ +98 21 6691 0317 m.mobin.moradi@gmail.com Tehran University of Medical Sciences scientific Pooya Payandemehr
Imama khomeini St. Hasan abad Sq
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 pooya_mehr@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Any adult patient (age>18) with acute pain who need analgesia 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 G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: patients with acute pain that treated with 0.3 mg/kg interavenous Ketamine and 2.5 mg interavenous Haloperidol. 2.5 mg Haloperidol diluted with distilled water up to 5ml will be injected by 5ml syringe in one minute through IV line .then immediately the calculated dosage of Ketamine will be diluted by distilled water up to 10ml and will be injected by 10ml syringe in two minutes through same IV line. Intervention group: patients with acute pain that treated with 1 μg/kg interavenous Fentanyl. In this group first 5ml distilled water will be injected through IV line in one minute insted of Haloperidol then the calculated amount of Fentanyl will be diluted with distilled water up to 10ml and will be injected by 10ml syringe in two minutes through IV line Pain score by Verbal Numerical Rating Scale (VNRS). Timepoint: 5,10,15 and 30 minutes after administration of medications. Method of measurement: Verbal Numerical Rating Scale (VNRS). Blood pressure. Timepoint: 5,10,15 and 30 minutes after administration of medications. Method of measurement: Sphygmomanometer. Agitation scale calculating with Richmond Agitation-Sedation Scale. Timepoint: When agitation appears. Method of measurement: Richmond Agitation-Sedation Scale. Need for rescue analgesic. Timepoint: 10 minutes after administration of medications. Method of measurement: Asking from patient about presence of pain. Tehran University of Medical Sciences Approved 2018-11-20 Ethics committee of Tehran University of Medical Sciences No. 63, Saduqi Ave., Jamalzadeh St Tehran Tehran Iran (Islamic Republic of)