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IRCT20211102052945N1 IRCT 2022-05-16 Mashhad University of Medical Sciences Effects of inhalation of rosemary fragrance on alleviating pain Effects of inhalation of rosemary fragrance on alleviating post orthopedic surgery pain(hip prosthesis placement) in ICU patients 2021-11-22 anticipated 64 Complete https://irct.ir/trial/59931 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Table of random numbers using the site: www.randomization.com, Blinding description: The study is a three-way blind study that includes participants, evaluators and data analysts. 3 Acute pain. Intervention 1: Intervention group: All patients undergo anesthesia after pre-medication with 1 mg midazolam and 3 micrograms/kg fentanyl with 2 mg/kg propofol and 0.5 mg/kg atracurium. At the end of the surgery, the patient is admitted to the surgical ICU after extubation and without recovery and receives the same care. For all patients, at the beginning of admission and every 3 hours, pain determination is performed according to the NRS scoring system and if the score is more than 3, 0.05 mg/kg of intravenous morphine is prescribed every 10 minutes to reduce the pain score to less than 4. In addition to these treatments, in the intervention group, a gauze impregnated with 5 drops of 3% rosemary essential oil (about one cc of essential oil on a 5*5 cm gauze) will be pinned to the patient's shirt and will be renewed every three hours. The score of pain and the required dose of morphine will be recorded every 3 hours for 24 hours. Intervention 2: Control group: All patients undergo anesthesia after pre-medication with 1 mg midazolam and 3 micrograms/kg fentanyl with 2 mg/kg propofol and 0.5 mg/kg atracurium. At the end of the surgery, the patient is admitted to the surgical ICU after extubation and without recovery and receives the same care. For all patients, at the beginning of admission and every 3 hours, pain determination is performed according to the NRS scoring system and if the score is more than 3, 0.05 mg/kg of intravenous morphine is prescribed every 10 minutes to reduce the pain score to less than 4. In addition to these treatments, in the control group, a gauze impregnated with 5 drops of sweet almond oil (about one cc of oil on a 5*5 cm gauze) will be pinned to the patient's shirt and will be renewed every three hours. The score of pain and the required dose of morphine will be recorded every 3 hours for 24 hours. 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 We wait to complete study
public Arash Peivandi Yazdi
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3885 3858 peivandia@mums.ac.ir Mashhad University of Medical Sciences scientific Arash Peivandi Yazdi
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3885 3858 peivandia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-70 year old ASA class III maximum Candidate for at least 24 hours stay in ICU Post orthopedic surgery and implantation of hip prosthesis 18 years 70 years Both Drug addiction Pregnancy and lactation Dissatisfaction Allergy to rosemary Any length of surgery or complications during and after surgery and leaving the same care Routine user of any analgesic in the period of 2 months before surgery Uncontrolled high blood pressure Epilepsy R52.0 Acute pain, not elsewhere classified Treatment - Drugs Placebo Intervention group: All patients undergo anesthesia after pre-medication with 1 mg midazolam and 3 micrograms/kg fentanyl with 2 mg/kg propofol and 0.5 mg/kg atracurium. At the end of the surgery, the patient is admitted to the surgical ICU after extubation and without recovery and receives the same care. For all patients, at the beginning of admission and every 3 hours, pain determination is performed according to the NRS scoring system and if the score is more than 3, 0.05 mg/kg of intravenous morphine is prescribed every 10 minutes to reduce the pain score to less than 4. In addition to these treatments, in the intervention group, a gauze impregnated with 5 drops of 3% rosemary essential oil (about one cc of essential oil on a 5*5 cm gauze) will be pinned to the patient's shirt and will be renewed every three hours. The score of pain and the required dose of morphine will be recorded every 3 hours for 24 hours. Control group: All patients undergo anesthesia after pre-medication with 1 mg midazolam and 3 micrograms/kg fentanyl with 2 mg/kg propofol and 0.5 mg/kg atracurium. At the end of the surgery, the patient is admitted to the surgical ICU after extubation and without recovery and receives the same care. For all patients, at the beginning of admission and every 3 hours, pain determination is performed according to the NRS scoring system and if the score is more than 3, 0.05 mg/kg of intravenous morphine is prescribed every 10 minutes to reduce the pain score to less than 4. In addition to these treatments, in the control group, a gauze impregnated with 5 drops of sweet almond oil (about one cc of oil on a 5*5 cm gauze) will be pinned to the patient's shirt and will be renewed every three hours. The score of pain and the required dose of morphine will be recorded every 3 hours for 24 hours. Patients' pain score based on NSR questionnaire. Timepoint: Measure the patient's pain at the time of admission to the ICU and every 3 hours for up to 24 hours. Method of measurement: Numeric Rating Scale questionnaire. Amount of morphine used. Timepoint: If necessary, once every ten minutes. Method of measurement: Record the prescribed drug by dose. Mashhad University of Medical Sciences Approved 2021-01-19 Ethics Committee of Mashhad University of Medical Sciences Ghoreishi building, Daneshgah street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)