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IRCT20201222049801N1 IRCT 2021-04-14 Mashhad University of Medical Sciences Evaluation of the effect of pain management program based on critical care pain observation tool (CPOT) on pain intensity and dose adjustment of analgesic in patients with decreased level of consciousness admitted to the intensive care units of Imam Reza Hospital in Mashhad . Evaluation of the effect of pain management program based on critical care pain observation tool (CPOT) on pain intensity and dose adjustment of analgesic in patients with decreased level of consciousness admitted to the intensive care units of Imam Reza Hospital in Mashhad . 2021-05-10 anticipated 70 Complete https://irct.ir/trial/53728 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients' assignment into two groups will be based on their ward. By simple random method, we select the required number of units as the intervention groups. The remaining units will also be assigned as the control groups, Blinding description: Patients are blinded about their group and the scale for pain measurment/sedative dosage. The statistcal analyzer is not aware about patient grouping. N/A pain. Intervention 1: Intervention group: At first, nurses measure the restlessness of patients based on the Richmond Instrument (RASS) to assess baseline status. Then, they measure the patient's pain before and after painful procedures (venipuncture, ABG test, change position, etc.) after 5, 15 and 30 minutes. The nurses will adjust the dose of prescribed sedatives based on the assessed pain. If CPOT = 3-5, intravenous fentanyl is given at 25 mcg per hour, and at CPOT = 6-8, intravenous fentanyl is given at 50 mcg per hour. This process will be done in 6 hours. Intervention 2: Nurses evaluate the level of pain based on the routine process of the unit, which includes physiological indicators (heart rate, respiratory rate, systolic and diastolic blood pressure, SPO2) before and 5, 15, and 30 minutes after the procedure (venipuncture, ABG test, etc.). Then, based on a 20% increase in each of the basic vital signs, such as heart rate or blood pressure, etc., they adjust the prescribed sedatives in the range determined by the physician. No - There is not a plan to make this available Justification or reason for not sharing IPD is No More information.
public Fatemeh Kouhi
School of Nursing and Midwifery, Ibn-e-Sina Ave. Mashhad
Mashhad Iran (Islamic Republic of) 9184898885 +98 51 3859 1511 koohif1@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Kouhi
School of Nursing and Midwifery, Ibn-e-Sina Ave. Mashhad
Mashhad Iran (Islamic Republic of) 9184898885 +98 51 3859 1511 koohif1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years Pulmonary patients subgroup (COPD, pneumonia, asthma, etc.) Inability to communicate verbally Having a systolic blood pressure greater than 100 mm Hg and a MAP> 65 Earn a score less than or equal to -1 and equal to or greater than -3 on the Richmond scale(-3≤RASS≤-1) At least 24 hours intubation and mechanical ventilation The need to use infusions of sedatives in the treatment program Admitted in the intensive care unit 18 years 65 years Both The patient with drug, alcohol and psychotropic abuse The patients with psychological disorders or history of epilepsy The patients with neuromuscular disease The patients with severe structural problems of the brain Allergy to sedatives (fentanyl, morphine) G89 Pain, not elsewhere classified Other Other Intervention group: At first, nurses measure the restlessness of patients based on the Richmond Instrument (RASS) to assess baseline status. Then, they measure the patient's pain before and after painful procedures (venipuncture, ABG test, change position, etc.) after 5, 15 and 30 minutes. The nurses will adjust the dose of prescribed sedatives based on the assessed pain. If CPOT = 3-5, intravenous fentanyl is given at 25 mcg per hour, and at CPOT = 6-8, intravenous fentanyl is given at 50 mcg per hour. This process will be done in 6 hours. Nurses evaluate the level of pain based on the routine process of the unit, which includes physiological indicators (heart rate, respiratory rate, systolic and diastolic blood pressure, SPO2) before and 5, 15, and 30 minutes after the procedure (venipuncture, ABG test, etc.). Then, based on a 20% increase in each of the basic vital signs, such as heart rate or blood pressure, etc., they adjust the prescribed sedatives in the range determined by the physician. Level of Pain. Timepoint: Before procedure and then 5, 15, 30 minutes after the procedures. Method of measurement: using critical care pain observation tool (CPOT) and (Behavioral Pain Scale) BPS. Mashhad University of Medical Sciences Approved 2021-02-09 Ethics Committee of Mashhad University of Medical Sciences Qureishi Builsing, Daneshgah Ave. Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)