Protocol summary
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Study aim
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Comparison of the effect of administering injectable dexamethasone with injectable ondansetron before upper endoscopy in reducing of PONV and Delirium in Children referred to Kashan Shahid Beheshti Hospital and Isfahan Imam Hossein Children's Hospital 2020
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Design
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Clinical trial with control group, with parallel groups, single blind, randomized, phase three on 60 patients (20 people in each of the three groups). For randomization from the website www. sealedenvelope.com/simple-randomiser/v1/lists was used.
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Settings and conduct
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This study is a single- blind clinical trial (participants did not know how to do the work) on upper endoscopic candidate children referred to Beheshti Hospital in Kashan and Imam Hossein in Isfahan, After receiving informed written consent from their parents. Patients are randomly allocated into dexamethasone, ondansetron and control groups. All patients undergo a pre-determined and uniform procedure and will undergo standard venipuncture and monitoring. To maintain anesthesia, an endoscopic mask with an endoscope passage and no leakage will be used at the same time as the endoscopy. Anesthesia is performed with midazolam and then propofol under the supervision of an anesthesiologist. Prior to UGIE, one group received 0.1 mg / kg intravenous dexamethasone, the other group received 0.15 mg / kg intravenous ondansetron, and the control group did not receive any medication.
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Participants/Inclusion and exclusion criteria
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Children 5 to 14 years of age, diagnosed by a gastroenterologist, are candidates for elective UGIE under deep anesthesia.
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Intervention groups
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In the two intervention groups, when the patient was sufficiently anesthetized, one group received dexamethasone 0.1 mg / kg and the other group, ondansetron 0.15 mg / kg, was not given the control group.
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Main outcome variables
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PONV, Delirium
General information
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Reason for update
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Over the past year, the presence of coronavirus pandemics and specific conditions in the country and consecutive closures have led to a significant reduction in referrals (elective patients) to the hospital and endoscopy unit.
Due to this, the process of collecting samples has become very slow
Considering that the estimated number of samples is 90 people and so far we have managed to collect 60 samples after 9 months, we need to adjust the number of samples. Note that my residency ended 7 months ago.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200809048343N1
Registration date:
2020-11-13, 1399/08/23
Registration timing:
registered_while_recruiting
Last update:
2021-04-28, 1400/02/08
Update count:
1
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Registration date
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2020-11-13, 1399/08/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-22, 1399/06/01
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Expected recruitment end date
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2021-02-18, 1399/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of Dexamethasone and Ondansetron on nausea,vomiting and delirium in children undergoing upper GI endoscopy
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Public title
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Comparison of the effect of Dexamethasone and Ondansetron on nausea , vomiting and delirium in children undergoing upper GI endoscopy
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children 5 to 14 years old who are candidates for UGIE with deep anesthesia
ASA stage : 1 , 2
Modified APFEL score 0 , 1
Exclusion criteria:
History of allergies to the drugs used in the study
History of previous chemotherapy
History of malignancy
History of metabolic disease
History of diabet
Upper respiratory tract anatomical disease
Treatment with Psychiatric drugs/Behavioural disorder
Children who have received sedatives before the procedure.
Children who are candidates for ERCP or emergency endoscopy
Children who receive higher doses of the drug due to the difficulty of the operation to prolong the duration of anesthesia
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Age
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From 5 years old to 14 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, the group receiving dexamethasone was coded with the letter A, the group receiving ondansetron with the letter B and the control group with the letter C, and then using the website
www. sealedenvelope.com/simple-randomiser/v1/lists
Randomization list was prepared by selecting a sample size of 60 (three groups of 30) and Permuted block randomization method (block size=6) (10 blocks of 6). Then, through the obtained randomization list, the subjects will be assigned to one of the three groups A or B or C. For example, suppose that in the first six blocks, the permutation method is AABCBC, so the first and second samples are group A (dexamethasone), the third and fifth samples are group B (ondansetron), and the fourth and sixth samples are Group C (control) will be assigned and the same will continue until the last sample (60th person).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, participants did not know how to work and prescribe drugs.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-13, 1399/04/23
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1399.053
Health conditions studied
1
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Description of health condition studied
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dyspepsia
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ICD-10 code
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R10.1
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ICD-10 code description
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Dyspepsia NOS /Epigastric pain
Primary outcomes
1
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Description
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Percentage of people with nausea and vomiting
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Timepoint
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Existence of nausea-vomiting after the intervention
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Method of measurement
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view
2
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Description
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Intensity of delirium in individuals
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Timepoint
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Measurement of delirium severity after intervention (during recovery)
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Method of measurement
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PAED Scaling Score
Intervention groups
1
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Description
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Intervention group: In the dexamethasone group, 0.1 mg / kg dexamethasone is injected when the anesthesia level is sufficient.
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Category
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Prevention
2
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Description
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Intervention group: In the ondansetron group, 0.15 mg / kg of ondansetron is injected when the anesthesia level is sufficient.
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Category
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Prevention
3
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Description
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Control group: In the control group, no drug is injected.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Its release schedule is not yet known
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When the data will become available and for how long
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Its release schedule is not yet known
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To whom data/document is available
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Its release schedule is not yet known
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Under which criteria data/document could be used
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Its release schedule is not yet known
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From where data/document is obtainable
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Its release schedule is not yet known
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What processes are involved for a request to access data/document
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Its release schedule is not yet known
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Comments
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