]>
IRCT20160307026950N7 IRCT 2018-07-13 Esfahan University of Medical Sciences The effects of ondansetron, dexamethasone and the combination of these two drugs in reducing nausea and vomiting in children Comparison of prophylactic effect of ondansetron, dexamethasone, combination of these drugs and placebo on decreasing nausea and vomiting in children aged 1 to 12 years undergoing upper gastrointestinal endoscopy 2016-01-21 anticipated 144 Complete https://irct.ir/trial/22211 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The convenience sampling was used for enrolment in this study. Patients were then randomly allocated to groups “A”, “B”,“C” and “D” using the sealed envelope to receive either ondansetron, dexamethasone, combination of the two drugs or placebo respectively, Blinding description: For blinding purpose, one of the anesthesiologists was responsible for patient randomization and induction of general anesthesia while another investigator who was unaware of group allocation was responsible for data collection. For the purpose of making the study double blind, patients were also kept unaware of group allocation. 3 nausea and vomiting. Intervention 1: The intervention group (o): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (0), 0.1 mg/kg of ondansetron will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. Intervention 2: The intervention group (d): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (d), 0.2 mg/kg of dexamethasone will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. Intervention 3: The intervention group (o+d): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (o+d), 0.1 mg/kg of ondansetron and 0.2 mg/kg of dexamethasone will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. Intervention 4: Control group (n): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (n), 1 milliliter of normal saline will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. 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
public Fatemeh Jafari
Hezar jarib street, Azadi square
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 fatemejfr1991@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemroayasedeh
Hezar Jarib street
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3626 5773 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children aged 1 to 12 years old ASA I and II candidates for upper gastrointestinal tract endoscopy parental consent for participation in the study 1 year 12 years Both History of allergy to study drug Severe respiratory disease Severe cardiovascular disease uncontrolled diseases R11 Nausea and vomiting Prevention Prevention Prevention Placebo The intervention group (o): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (0), 0.1 mg/kg of ondansetron will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. The intervention group (d): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (d), 0.2 mg/kg of dexamethasone will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. The intervention group (o+d): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (o+d), 0.1 mg/kg of ondansetron and 0.2 mg/kg of dexamethasone will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. Control group (n): First, informed consent is obtained from the child's parents. After placement of the patients on the bed and attaching standard monitoring devices including the pulse oximeter, capnography and ECG, the vital signs will be recorded and the medications will be administered bolus and then through infusion. In group (n), 1 milliliter of normal saline will be prescribed and the average arterial blood pressure and heart rate will be recorded at baseline, and then every 5 minutes until the end of the endoscopy process, at recovery admission and then every 15 minutes until the recovery discharge. Heart rate. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: Pulse oximetry device. Nausea and vomiting. Timepoint: Every 15 minutes in recovery room, and then 2, 4 and 6 hours after endoscopy. Method of measurement: Baxter Retching Face Nausea Scale. Mean arterial blood pressure. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: non invasive blood pressure sphygmomanometer. Arterial oxygen saturation. Timepoint: Before the intervention (0), then every 5 minutes until the end of endoscopy and then every 15 minutes until discharge the recovery. Method of measurement: Pulse oximetry device. Duration of stay in recovery. Timepoint: From recovery admission to recovery discharge. Method of measurement: Watch or clock. Esfahan University of Medical Sciences Approved 2015-05-27 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)