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IRCT20200602047633N2 IRCT 2023-08-16 Yazd University of Medical Sciences Comparison of Intranasal Ketamine Spray and Intravenous Morphine in Reducing Headache in Patients with Headache Comparison of Intranasal Ketamine Spray and Intravenous Morphine in Reducing Headache in Patients with Headache; A Randomized Double-Blinded Clinical Trial 2021-09-23 anticipated 110 Complete https://irct.ir/trial/71883 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number table Based on a random sequence of numbers from Random.org, a table will be prepared, with the first Hundred consecutive numbers in Group A, the next Hundred consecutive numbers in Group B. These numbers will be assigned to each patient in order of referral, Blinding description: The drug is prepared and prescribed by the triage nurse based on which group the patient is in and none of the patients and the evaluating physician will know the type of prescription drug. 2-3 Patients with Headache. Intervention 1: Intervention group: 50 patients who were treated with intranasal ketamine at a dose of 0.7 mg/kg (the maximum dose was considered 40 mg) in the form of three puffs inside each nostril (each puff containing 7 mg of ketamine) and 10 cc of normal intravenous saline were injected slowly. Intervention 2: Control group: 50 patients were treated with placebo nasal spray and 0.1 mg/kg intravenous morphine (the maximum dose was considered 5 mg) were injected slowly which was diluted with 10 cc of normal intravenous saline. 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 Dr.Soheila Azimi
Ebne Sina Blvd
Yazd Iran (Islamic Republic of) 8913893111 +98 35 3828 2682 soheila.azimi1987@gmail.com Yazd University of Medical Sciences scientific Dr.Soheila Azimi
Ebne Sina Blvd
Yazd Iran (Islamic Republic of) 8913893111 +98 35 3828 2682 soheila.azimi1987@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Trauma patients with trauma pain with a pain score greater than 4 Age over 14 years Age less than 65 years 15 years 65 years Both G44 Other headache syndromes Treatment - Drugs Treatment - Drugs Intervention group: 50 patients who were treated with intranasal ketamine at a dose of 0.7 mg/kg (the maximum dose was considered 40 mg) in the form of three puffs inside each nostril (each puff containing 7 mg of ketamine) and 10 cc of normal intravenous saline were injected slowly. Control group: 50 patients were treated with placebo nasal spray and 0.1 mg/kg intravenous morphine (the maximum dose was considered 5 mg) were injected slowly which was diluted with 10 cc of normal intravenous saline. The time to start responding to treatment. Timepoint: Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment. Method of measurement: Visual Analog Scale (VAS). Creating analgesia which patient's intensity pain goes below than 5. Timepoint: Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment. Method of measurement: Visual analog scale (VAS). The rate of complications in both groups. Timepoint: At the end of the study. Method of measurement: Calculate the number. Yazd University of Medical Sciences Approved 2021-09-15 Ethics committee of Shahid Sadoughi University of Medical Sciences Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)