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IRCT20170829035984N1 IRCT 2018-01-03 Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences The effect of applying pain control algorithm on physiologic indexes and weaning Comparison of applying and non-applying of pain control algorithm on physiologic indexes and weaning in patients hospitalized in intensive care units 2017-07-23 anticipated 396 Complete https://irct.ir/trial/27038 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: ----------, Randomization description: Patients will be allocated to groups using blocking randomization method. N/A Condition 1: Pain. Condition 2: Weaning from ventilator status. Condition 3: Physiological indices. Intervention 1: Intervention group: Pain and physiological indices (heart rate, diastolic and systolic blood pressures, respiratory rate, and level of arterial oxygen saturation) of patients will be assessed and recorded in three shift works each 4 hours. If the pain will be more than 5, then nurse should alleviate pain with pain control algorithm. Firstly Morphine with dosage of 0.1 milligram per weight will be injected using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded. If the pain will be more than 5, a single dosage of Morphine will be injected again using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded again. Pain and physiological indices will be assessed and recorded each 60 minutes until obtaining of pain score less than 5, and after that each 4 hours until complete weaning of patient from ventilator. If the pain will be less than 5, then daily assessment for weaning will be implemented. Intervention 2: Control group: Pain and physiological indices (heart rate, diastolic and systolic blood pressures, respiratory rate, and level of arterial oxygen saturation) of patients will be assessed and recorded in three shift works each 4 hours. If the pain will be more than 5, then nurse should alleviate pain without pain control algorithm based on hospital routine. One hour after intervention pain and physiological indices will be assessed and recorded again. Further assessment will be done based on nursing diagnosis. If the pain will be less than 5, then daily assessment for weaning will be implemented. Yes - There is a plan to make this available What will be shared: Only a part of patients demographical data and main outcomes will be shared. When: Six months after data publishing To whom: Data will be available only for researchers working on academic and university associations. Conditions: Mention of study name and authors name Where to obtain: Zahra Karimi: School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran How to obtain: At last one month after request Comments:
public Zahra Karimi
Faculty of Midwifery and Nursing, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3336 7543 zkarimi493@gmail.com Ahvaz Jundishapur University of Medical Sciences scientific Dr Shahram Baraz Pordjanjani
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 9092 sharambaraz@yahoo.com Ahvaz Jundishapur University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having level of consciences between 3-5 based on Glasgow Coma Scale Having airway or tracheostomy tubes Being under mechanical ventilation using synchronized intermittent mandatory ventilation mode without intake of muscle relaxants Ability to move at least one of limbs Having stable hemodynamic 18 years 60 years Both Having severe face injuries Inability for verbal communication Being under mechanical ventilation more than 48 hours Having smoking and cigarettes addiction Suffering from cancers Sensitivity to Morphine and Fentanyl drugs Intake of muscle relaxants using intermittent infusion Having renal and liver diseases M79.6 Z99.11 R09.89 Pain in limb Dependence on respirator [ventilator] status Other specified symptoms and signs involving the circulatory and respiratory systems Treatment - Drugs Treatment - Drugs Intervention group: Pain and physiological indices (heart rate, diastolic and systolic blood pressures, respiratory rate, and level of arterial oxygen saturation) of patients will be assessed and recorded in three shift works each 4 hours. If the pain will be more than 5, then nurse should alleviate pain with pain control algorithm. Firstly Morphine with dosage of 0.1 milligram per weight will be injected using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded. If the pain will be more than 5, a single dosage of Morphine will be injected again using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded again. Pain and physiological indices will be assessed and recorded each 60 minutes until obtaining of pain score less than 5, and after that each 4 hours until complete weaning of patient from ventilator. If the pain will be less than 5, then daily assessment for weaning will be implemented. Control group: Pain and physiological indices (heart rate, diastolic and systolic blood pressures, respiratory rate, and level of arterial oxygen saturation) of patients will be assessed and recorded in three shift works each 4 hours. If the pain will be more than 5, then nurse should alleviate pain without pain control algorithm based on hospital routine. One hour after intervention pain and physiological indices will be assessed and recorded again. Further assessment will be done based on nursing diagnosis. If the pain will be less than 5, then daily assessment for weaning will be implemented. Pain. Timepoint: Before and after drug intervention. Method of measurement: Behavioral pain scale. Physiological indices. Timepoint: Before and after drug intervention. Method of measurement: Researcher made checklist. Weaning form ventilator. Timepoint: Daily. Method of measurement: Researcher made checklist. ------. Timepoint: ------. Method of measurement: ------. Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences Approved 2017-07-08 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan Ahvaz Khouzestan Iran (Islamic Republic of)