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IRCT20220107053654N1 IRCT 2022-02-22 Tehran University of Medical Sciences The effect of intravenous dexamethasone and acetaminophen on postoperative pain and agitation children undergoing general anesthesia for dental rehabilitation Comparison of intravenous dexamethasone and intravenous acetaminophen (apotel) on postoperative pain and agitation of 2-6-year-old children undergoing general anesthesia for dental rehabilitation 2022-03-01 anticipated 40 Complete https://irct.ir/trial/61538 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple and its unit is the individual. Randomizing the table of random numbers is our tool. Patients will be randomly assigned treatment types. In this way, each vial is randomly selected based on the envelope randomization process, and an operating room nurse who is not a member of the research team selects the drugs that will be used. Due to this, neither the patient nor the researcher is aware of the type of treatment chosen, ensuring blindness in the bilateral study, Blinding description: The present study is double-blind. For blinding the contents of the vials will be specified with the code A (intravenous dexamethasone) and B (Apotel), and will be placed inside sealed envelopes (envelope); An operating room nurse who is not a member of the research team randomly selects the drugs used. The nurse registers the variables at the end of the operation and participants are blind to the content of the syringes used. 2 The amount of pain after dental treatment under general anesthesia. Intervention 1: Intervention group 1: 20 children aged 2-6 years referred to the pediatric ward of Tehran University of Medical Sciences who are candidates for dental treatment under general anesthesia.These patients receive intravenous dexamethasone 0.5 mg/kg immediately after induction after obtaining informed consent and preparing the patient for treatment under anesthesia.Except for fentanyl used at the beginning of anesthesia, no opioid analgesics NSAIDs, or antiemetics are used 24 hours before and during the operation, and none of the patients receive local anesthesia before dental interventions. At the end of the operation, after the patient returns to breathing, the reverse of the neuromuscular block is slowly injected and the patient is extruded while awake. Treatment is performed and within the first 30 minutes after recovery as well as the time of discharge, pain, nausea, and vomiting in the presence/absence of it, mild/moderate/severe sore throat and agitation are evaluated and recorded by a trained nurse. During telephone calls with parents within 24 hours after discharge, the presence of sore throat nausea, and vomiting are recorded again. Intervention 2: Intervention group 2: 20 children aged 2-6 years referred to the pediatric ward of Tehran University of Medical Sciences who are candidates for dental treatment under general anesthesia.After obtaining informed consent and preparing the patient for treatment under anesthesia, these patients receive 15 mg/kg of Apotel in ten minutes in the last 15 minutes.During the treatment, except for fentanyl used at the beginning of anesthesia, no opioid analgesics NSAIDs, or anti-nausea is used in the 24 hours before and during the operation, and none of the patients receive local anesthesia before dental interventions. At the end of the operation, after the patient returns to breathing, the reverse of the neuromuscular block is slowly injected and the patient is extruded while awake. Within the first 30 minutes after recovery, as well as the time of discharge, pain, nausea, and vomiting in the presence/absence of it, mild/moderate/severe sore throat and agitation are assessed and recorded by a trained nurse. During telephone calls with parents within 24 hours after discharge, the presence of sore throat nausea, and vomiting are recorded again. 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 There is no more information
public Saeide Mokhtari Khoei
North Karegar St,Tehran-Iran
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 4279 4500 sa.mokhtari@yahoo.com Tehran University of Medical Sciences scientific Saeide Mokhtari Khoei
North Karegar St,Tehran-Iran
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 4279 4500 sa.mokhtari@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Children 2 to 6 years old are candidates for general anesthesia for dental rehabilitation Children with ASA I, II status Consent of the child and the child's parents to participate in the study 2 years 6 years Both Patients need a tooth extraction Patients with a history of chronic systemic diseases Patients with a history of allergies to any of the drugs used in the study Patients with a history of respiratory problems, allergies, motor, and mental illness Z48.814 Encounter for surgical aftercare following surgery on the teeth or oral cavity N/A N/A Intervention group 1: 20 children aged 2-6 years referred to the pediatric ward of Tehran University of Medical Sciences who are candidates for dental treatment under general anesthesia.These patients receive intravenous dexamethasone 0.5 mg/kg immediately after induction after obtaining informed consent and preparing the patient for treatment under anesthesia.Except for fentanyl used at the beginning of anesthesia, no opioid analgesics NSAIDs, or antiemetics are used 24 hours before and during the operation, and none of the patients receive local anesthesia before dental interventions. At the end of the operation, after the patient returns to breathing, the reverse of the neuromuscular block is slowly injected and the patient is extruded while awake. Treatment is performed and within the first 30 minutes after recovery as well as the time of discharge, pain, nausea, and vomiting in the presence/absence of it, mild/moderate/severe sore throat and agitation are evaluated and recorded by a trained nurse. During telephone calls with parents within 24 hours after discharge, the presence of sore throat nausea, and vomiting are recorded again. Intervention group 2: 20 children aged 2-6 years referred to the pediatric ward of Tehran University of Medical Sciences who are candidates for dental treatment under general anesthesia.After obtaining informed consent and preparing the patient for treatment under anesthesia, these patients receive 15 mg/kg of Apotel in ten minutes in the last 15 minutes.During the treatment, except for fentanyl used at the beginning of anesthesia, no opioid analgesics NSAIDs, or anti-nausea is used in the 24 hours before and during the operation, and none of the patients receive local anesthesia before dental interventions. At the end of the operation, after the patient returns to breathing, the reverse of the neuromuscular block is slowly injected and the patient is extruded while awake. Within the first 30 minutes after recovery, as well as the time of discharge, pain, nausea, and vomiting in the presence/absence of it, mild/moderate/severe sore throat and agitation are assessed and recorded by a trained nurse. During telephone calls with parents within 24 hours after discharge, the presence of sore throat nausea, and vomiting are recorded again. Pain measurement. Timepoint: During the first 30 minutes after recovery, discharge time, 24 hours after discharge. Method of measurement: Children’s hospital of eastern Ontario pain score: CHEOPS. Nausea and vomiting. Timepoint: During the first 30 minutes after recovery, discharge time, 24 hours after discharge. Method of measurement: Checklist: its presence / absence. Sore throat. Timepoint: During the first 30 minutes after recovery, discharge time, 24 hours after discharge. Method of measurement: Checklist: Mild / Medium / Severe. Agitation. Timepoint: During the first 30 minutes after recovery, discharge time, 24 hours after discharge. Method of measurement: PAED score (pediatric agitation emergence delirium score). Tehran University of Medical Sciences Approved 2021-11-29 Ethics Committee of Tehran University of Medical Sciences Central office of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)