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IRCT20180929041173N1 IRCT 2018-10-26 Tehran University of Medical Sciences Antiemetic effect of Dexamethasone in pediatric endosocopy Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients 2018-11-03 anticipated 98 Complete https://irct.ir/trial/34638 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A statistical computer program is used to make random block stratified individual assignments with user selected block sizes. The psuedonumber generator is a linear congruential algorithm of Park and Milller with Bays-Durham shuffling. The random sheets will be given directly to nurse administrating the drugs and neither the participants nor the researcher collecting the data will be informed of the method of drug allocation to patients, Blinding description: The randomly allocated list of patients will be given exclusively to the nurse administrating the drugs. Participants, gastroenterologist performing endoscopy, attending anesthesiologist, recovery nurse and the researcher collecting data will not be informed of the method of drug allocation to patients. (The parents of participants will be thoroughly informed that this clinical trial uses a randomized method before giving consent). 3 Post endoscopy nausea and vomiting. Intervention 1: Intervention group: After anesthesia is induced and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously. Intervention 2: Control group: After anesthesia is induced and deepened, same volume of normal saline is administered to patients intravenously. https://journals.lww.com/jpgn/Abstract/2019/09000/Dexamethasone_Reduces_Postoperative_Nausea_in.3.aspx Objectives: We aimed to evaluate the effect of a single dose of preoperative dexamethasone on postoperative nausea and vomiting (PONV), a frequent complication and a major cause of delayed recovery in pediatric upper gastrointestinal endoscopy (UGIE) under sedation. Methods: In this double-blind randomized controlled study, 98 children aged 2 to 14, with American Society of Anesthesiologists status I to II, and undergoing elective UGIE with deep sedation were included and randomly assigned to 2 groups. Preoperatively, after anesthesia induction with sodium thiopental and maintenance with sevoflurane, patients in the intervention (n = 49) and control (n = 49) groups, respectively received 0.1 mg/kg i.v. dexamethasone and 2 cm3 i.v. 0.9% saline. Postoperatively, PONV incidence was measured as the primary outcome. Results: PONV incidence was significantly less in dexamethasone group (8.2%) compared to the control group (26.5%) (difference = 18.3%, 95% confidence interval: 3.4%−33%, P = 0.016). For secondary outcomes, between-group differences were not statistically significant: incidence of bronchospasm or laryngospasm (both 4.1%, P = 1); emergence delirium assessed with Pediatric Anesthesia Emergence Delirium scale (5.9 ± 3.4 vs 5.7 ± 3.2, P = 0.751); Modified Aldrete score at 0 minutes (9.4 ± 0.8 vs 9.3 ± 0.9, P = 0.909) and at 5 minutes (9.5 ± 0.7 vs 9.4 ± 0.9, P = 0.527); and recovery time (21.1 ± 6.6 vs 23.4 ± 8.6 minutes, P = 0.130). Conclusions: A single preoperative dose of i.v. dexamethasone reduces PONV in children undergoing elective UGIE with deep sedation, but has no significant effect on the patient recovery time or the incidence of postoperative bronchospasm or laryngospasm and emergence delirium. 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 No more information is available
public Hamed Moheimani
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Tehran Iran (Islamic Republic of) 1417653761 +98 21 81631 h-moheimani@alumnus.tums.ac.ir Tehran University of Medical Sciences scientific Hamed Moheimani
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
Tehran Iran (Islamic Republic of) 1417653761 +98 21 81631 h-moheimani@alumnus.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All 2 to 14 year-old children, candidate for an elective upper GI endoscopy, according to the pediatric gastroenterologist diagnosis 2 years 14 years Both Patients with a history of hypersensitivity to the drugs studied Patients with a history of metabolic disease or diabetes Patients with anatomical upper airway disorders Patients diagnosed with behavioral disorders or currently taking psychiatric medication Patients with a history of undergoing chemotherapy Patients who have taken a sedative/hypnotic drug prior to endoscopy Patients who are a candidate for an emergency endoscopy Patients whose operation is complicated (e.g. by bleeding) and takes too long to be completed Patients without a parental informed consent R11 Nausea and vomiting Treatment - Drugs Placebo Intervention group: After anesthesia is induced and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously Control group: After anesthesia is induced and deepened, same volume of normal saline is administered to patients intravenously Incidence of nausea/vomiting. Timepoint: Recording the incidence of nausea/vomiting, evaluated during patients' stay in the post-anesthesia recovery room. Method of measurement: Investigator evaluation and examination. Post anesthesia emergence delirium. Timepoint: Recording the highest score of patients on PAED sacle, during their stay in the post-anesthesia recovery room. Method of measurement: Pediatric Anesthesia Emergence Delirium (PAED) Scale. Incidence of bronchospasm/laryngospasm. Timepoint: Recording the incidence bronchospasm/laryngospasm, evaluated during patients' stay in the post-anesthesia recovery room. Method of measurement: Investigator evaluation and examination. Time needed for patient recovery after endoscopy. Timepoint: Recording the time of patients stay in the post-anesthesia recovery room after endoscopy. Method of measurement: Subtracting the recorded time of entry to the recovery room, from the time the patient is eligible for transfer to the secondary recovery facilities. Patients recovery state. Timepoint: Patients score on the Modified Aldrete scale is calculated and recorded at the time of entry to post-anesthesia recovery room, 5 minutes after entry, and at the time of discharge. Method of measurement: Modified Aldrete scale. Tehran University of Medical Sciences Approved 2018-10-17 Ethics committee of Tehran University of Medical Sciences Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761 Tehran Tehran Iran (Islamic Republic of)