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IRCT20150919024080N17 IRCT 2020-08-26 Khoram-Abad University of Medical Sciences Effect of analgesia-sedation protocol on pain, agitation and cardiovascular response of trauma Effect of analgesia-sedation protocol on pain, agitation and cardiovascular response of trauma patient in the surgical intensive care unit 2020-08-22 anticipated 84 Complete https://irct.ir/trial/50324 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were assigned to two groups of protocol and control based on stratified random sampling method. Classes were also made based on gender, age group and severity of trauma (a total of 8 classes) and within each class random permutation blocks were used to assign patients to two groups. A table of random numbers is also used to construct the above blocks, Blinding description: Patients participating in the study, pain examiners who included two trained nurses and also data analysts are not aware of the allocation of participants in the control and protocol groups. Due to the nature of the study and prescribing of the drug, the prescribing nurse and the coordinator or consultant of the research team (specialist in pain medicine and intensive care) were aware of the allocation of samples. 3 trauma. Intervention 1: Intervention group: In the protocol (intervention) group, first, a comprehensive examination of the patient was performed. After, the patient entered the ward, simultaneously vital signs (blood pressure, pulse, respiration) using chart form, GCS, the disease severity using APACHE II tool, incidence and severity of pain using BPS BPS - NI, NRS tools and the level of restlessness were checked and recorded using RASS tool every 1-4 hours. Patients were divided into three groups with mild relief, severe relief and normal relief, based on the initial comprehensive assessment. Then the implementation of the protocol started. Before the implementation of the protocol, patients were checked in terms of probable problems including the need for tracheal tube suction, urinary catheter control for urinary retention, and also being in the right position. If restlessness persisted, despite the above non-pharmacological interventions, based on the pain intensity and level of restlessness according to the protocol, an analgesic or sedative was prescribed intravenously / intramuscularly by the nurse in consultation with the intensive care physician (head of department). After drug administration, reassessment of pain and restlessness of the patient based on the desired instruments (BPS, BPS-NI, NRS and RASS) was performed every hour according to the protocol. In the implementation of the protocol, giving priority to the pain ladder, prescribing analgesics over sedatives, intermittent administration of analgesics or sedatives (bolus prescriptions), over continuous administration and also prescribing lighter sedative levels than heavier sedative levels (deep) and non-steroidal anti-inflammatory drugs were targeted. The dose of bolus was administered with an interval of 5 minutes. The maximum dose of bolus was three doses and if necessary, according to re-evaluations, the dose of continuous infusion was during 60 minutes. If pain or restlessness was not controlled with bolus doses, continuous infusions were started with the same analgesic or sedative drugs used as bolus (e.g., in fentanyl bolus, continuous fentanyl infusion, and in midazolam bolus, continuous midazolam infusion, etc.). Of course, the bolus dose required for sedation was determined and corresponded to the current dose of continuous infusion (for example, 100 micrograms IV push bolus fentanyl for a patient with a continuous infusion of 100 micrograms fentanyl per hour, if necessary) as long the NRS is less than 3 and the BPS, BPS-NI less than 5, or the pain score decreases by at least 3 points, or the pain is acceptable to the patient. Analgesics in the protocol mainly included Apotel, Ketorolac, and Fentanyl, Hydromorphone, Morphine, Remifentanil and sedatives including Propofol, Dexmethomidine, Midazolam, and Lorazepam. Depending on the assessment of pain and restlessness and depending on which group the patient belongs to in terms of sedation (light, heavy, and normal), the dose of these drugs was increased or decreased. The starting time and dose of analgesic and sedative drug were recorded and monitored. Intervention 2: Control group: In the control group, the routine method of pain assessment was not performed comprehensively and regularly. Usually the categorical scale was used to assess the pain and the patients themselves expressed the pain (conscious, without connecting to a ventilator) and to determine the level of restlessness, no tool was used to measure delirium and restlessness. Routine sedatives and analgesics were prescribed in the ward by the doctor and anesthetist if necessary. These included opioids (30 mg injectable pethidine TDS or PRN, 5 mg morphine PRN and 5 mg methadone BID, 5 mg midazolam PRN, as well as for patients connected to a ventilator, infusion of 1 to 2 mg midazolam and morphine per hour was done) used for sedation and pain management. In the routine method, the nurse did not play an active role in deciding to prescribe analgesic-sedative drugs, and the medication was prescribed solely by the physician. In the control group, routine non-pharmacological care of the nurse, such as moving, maintaining a comfortable position and reducing ambient light at night, was performed to manage pain and restlessness. 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 Its release schedule is still unclear
public Maryam Hashemi
No. 22, Imam Reza Alley, Shariati St.
Khorramabad Iran (Islamic Republic of) 6813972683 +98 66 3331 7759 maryamhashemi5353@gmail.com Khoram-Abad University of Medical Sciences scientific Mohammad Gholami
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
Khorramabad Iran (Islamic Republic of) 6814993165 +98 66 3312 0139 gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Trauma patients (abdominal, chest, orthopedics trauma, and etc.) Patients need a ventilator with a minimum duration of 24 hours connected to the ventilator. Patients separated from the ventilator The minimum duration of separation from the ventilator is 24 hours. Willingness to participate in the study. Being able to self-report pain or express pain behaviors. level of consciousness equal and above 7 The minimum length of hospital stay in the ICU should be 48 hours. No pregnancy. No coagulation disorders 18 years 89 years Both Transfer to home and using palliative care unit (end of life). Plant life, quadriplegia and the need for continuous infusion of nerve blockers and inhaled prostacyclins. Deep sedation to quit alcohol. Need for continuous infusion of sedative or analgesic for more than 24 hours. Patients with permanent brain injury admitted to neurosurgery wards. Deep sedation for treatment of active seizures. Patients in the final stage of kidney and liver failure. Cardiac arrest. Neurovascular injury, burns, ear, nose and throat surgeries, maxillofacial surgery, or plastic surgery to place a flap on the head or neck. G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Intervention group: In the protocol (intervention) group, first, a comprehensive examination of the patient was performed. After, the patient entered the ward, simultaneously vital signs (blood pressure, pulse, respiration) using chart form, GCS, the disease severity using APACHE II tool, incidence and severity of pain using BPS BPS - NI, NRS tools and the level of restlessness were checked and recorded using RASS tool every 1-4 hours. Patients were divided into three groups with mild relief, severe relief and normal relief, based on the initial comprehensive assessment. Then the implementation of the protocol started. Before the implementation of the protocol, patients were checked in terms of probable problems including the need for tracheal tube suction, urinary catheter control for urinary retention, and also being in the right position. If restlessness persisted, despite the above non-pharmacological interventions, based on the pain intensity and level of restlessness according to the protocol, an analgesic or sedative was prescribed intravenously / intramuscularly by the nurse in consultation with the intensive care physician (head of department). After drug administration, reassessment of pain and restlessness of the patient based on the desired instruments (BPS, BPS-NI, NRS and RASS) was performed every hour according to the protocol. In the implementation of the protocol, giving priority to the pain ladder, prescribing analgesics over sedatives, intermittent administration of analgesics or sedatives (bolus prescriptions), over continuous administration and also prescribing lighter sedative levels than heavier sedative levels (deep) and non-steroidal anti-inflammatory drugs were targeted. The dose of bolus was administered with an interval of 5 minutes. The maximum dose of bolus was three doses and if necessary, according to re-evaluations, the dose of continuous infusion was during 60 minutes. If pain or restlessness was not controlled with bolus doses, continuous infusions were started with the same analgesic or sedative drugs used as bolus (e.g., in fentanyl bolus, continuous fentanyl infusion, and in midazolam bolus, continuous midazolam infusion, etc.). Of course, the bolus dose required for sedation was determined and corresponded to the current dose of continuous infusion (for example, 100 micrograms IV push bolus fentanyl for a patient with a continuous infusion of 100 micrograms fentanyl per hour, if necessary) as long the NRS is less than 3 and the BPS, BPS-NI less than 5, or the pain score decreases by at least 3 points, or the pain is acceptable to the patient. Analgesics in the protocol mainly included Apotel, Ketorolac, and Fentanyl, Hydromorphone, Morphine, Remifentanil and sedatives including Propofol, Dexmethomidine, Midazolam, and Lorazepam. Depending on the assessment of pain and restlessness and depending on which group the patient belongs to in terms of sedation (light, heavy, and normal), the dose of these drugs was increased or decreased. The starting time and dose of analgesic and sedative drug were recorded and monitored Control group: In the control group, the routine method of pain assessment was not performed comprehensively and regularly. Usually the categorical scale was used to assess the pain and the patients themselves expressed the pain (conscious, without connecting to a ventilator) and to determine the level of restlessness, no tool was used to measure delirium and restlessness. Routine sedatives and analgesics were prescribed in the ward by the doctor and anesthetist if necessary. These included opioids (30 mg injectable pethidine TDS or PRN, 5 mg morphine PRN and 5 mg methadone BID, 5 mg midazolam PRN, as well as for patients connected to a ventilator, infusion of 1 to 2 mg midazolam and morphine per hour was done) used for sedation and pain management. In the routine method, the nurse did not play an active role in deciding to prescribe analgesic-sedative drugs, and the medication was prescribed solely by the physician. In the control group, routine non-pharmacological care of the nurse, such as moving, maintaining a comfortable position and reducing ambient light at night, was performed to manage pain and restlessness. Pain intensity in trauma patients in special surgical wards. Timepoint: Twice a day at 8-10 and 18-16 hours for a maximum of 4 days. Method of measurement: Behavioral Pain Scale BPS-NI, BPS, NRS Pain Numerical Scale. Severity of restlessness in trauma patients in surgical wards. Timepoint: Twice a day at 8-10 and 18-16 hours for a maximum of 4 days. Method of measurement: Richmond Scale (RASS). Incidence of delirium in trauma patients in special surgical wards. Timepoint: Once a day for 18-16 hours for a maximum of 4 days. Method of measurement: CAM-ICU scale. Cardiovascular response of trauma patients in surgical special wards. Timepoint: Before and after each drug intervention. Method of measurement: Blood pressure with Blood pressure monitor and pulse monitoring with cardiac and respiratory monitoring with manual count in one minute. Lorestan University of Medical Sciences Approved 2020-08-05 Lorestan Medical Sciences Ethics Committee Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology Khorramabad Lorestan Iran (Islamic Republic of)