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IRCT20101220005426N10 IRCT 2021-08-18 Kerman University of Medical Sciences Effect of Acetaminophen on hemodynamic changes during intubation Evaluation of the effect of Acetaminophen on hemodynamic changes during intubation in children undergoing hypospadias surgery 2021-09-23 anticipated 126 Complete https://irct.ir/trial/58032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization method is used to randomize people into two groups. In this way, quadruple blocks are used. In each quadruple blocks, 2 people are assigned to group A (intervention group) and 2 people to group B (control group); So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. From the blocks, one is first selected at random and according to its order, the samples are assigned to two groups (for example, if the BBAA block is selected, the first two patients are assigned to group B and the next two patients to group A). R statistical software is used for random block allocation. Unit of randomization is individual, Blinding description: In order to double-blind the study, patients and the person responsible for data collection are unaware of the intervention. Patients are unaware of the type of intervention and the group in which they are due to their young age. Also, the person in charge of data collection who performs all data recording operations and question from the patient or the patient's companion is also unaware of the intervention and the group in which the patient is. 2 Condition 1: Intubation. Condition 2: Hypospadias. Intervention 1: Intervention group: Receiving Acetaminophen suppository at a dose of 15 mg per kg body weight of the child once rectally two hours before surgery (before intubation). Intervention 2: Control group: Children do not take Acetaminophen suppositories. 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 Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mehdia50@gmail.com Kerman University of Medical Sciences scientific Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mehdia50@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Children undergoing hypospadias surgery Children aged 2 to 7 years 2 years 7 years Male Known allergy to Acetaminophen Renal or hepatic impairment Bleeding disorders History of known heart or respiratory disease History of seizures Neurological or neuromuscular disorders History of chronic pain or use of pain medication Predict hard intubation T88.4 Q54 Failed or difficult intubation Hypospadias Rehabilitation N/A Intervention group: Receiving Acetaminophen suppository at a dose of 15 mg per kg body weight of the child once rectally two hours before surgery (before intubation) Control group: Children do not take Acetaminophen suppositories Systolic blood pressure. Timepoint: Checking of systolic blood pressure before induction of anesthesia, after induction of anesthesia and at 1, 3, 6 and 9 minutes after intubation. Method of measurement: Patient monitoring system. Diastolic blood pressure. Timepoint: Checking of diastolic blood pressure before induction of anesthesia, after induction of anesthesia and at 1, 3, 6 and 9 minutes after intubation. Method of measurement: Patient monitoring system. Heart rate. Timepoint: Checking of heart rate before induction of anesthesia, after induction of anesthesia and at 1, 3, 6 and 9 minutes after intubation. Method of measurement: Patient monitoring system. Incidence of nausea and vomiting. Timepoint: Evaluation of nausea and vomiting during recovery and 6 hours after recovery. Method of measurement: Ask the child or parents of the child. Kerman University of Medical Sciences Approved 2021-05-03 Ethics Committee of Kerman University of Medical Sciences Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman Kerman Kerman Iran (Islamic Republic of)