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
Determination of preventive effect of Ondansetron, Dexamethasone, and combination of the two drugs on reduction of Nausea and Vomiting in children aged 1 to 12 years under upper gastrointestinal endoscopy and its comparison with the control group.
Design
This triple blind, randomized clinical trial with parallel group design consists of 146 children at the age of 1-12 years old who will undergo upper gastrointestinal endoscopy. They will randomly be divided into 4 36-member groups.
Settings and conduct
This study was conducted at Imam Hossein Hospital in Isfahan in 2016. The target population of the study was consisted of children aged 1 to 12 years who were candidates for endoscopy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children of 1 to 12 years of age, Endoscopy candidate, ASA class I, II; Parental consent.
Exclusion criteria: Allergy to study drug; severe cardiovascular disease; severe pulmonary disease; uncontrolled diseases
Intervention groups
Intervention group 1: received 0.1 mg/kg of Ondansetron, Intervention group 2:0.2 mg/kg Dexamethasone, Intervention group 3: the combination of the two above mentioned drugs, Intervention group 4: Normal Saline (Placebo) was given with the same volume.
Main outcome variables
nausea and vomiting; Duration of stay in recovery; mean arterial blood pressure; heart rate; arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N7
Registration date:2018-07-13, 1397/04/22
Registration timing:retrospective
Last update:2018-07-13, 1397/04/22
Update count:0
Registration date
2018-07-13, 1397/04/22
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2016-07-21, 1395/04/31
Actual recruitment end date
2017-04-20, 1396/01/31
Trial completion date
empty
Scientific title
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
Public title
The effects of ondansetron, dexamethasone and the combination of these two drugs in reducing nausea and vomiting in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1 to 12 years old
ASA I and II
candidates for upper gastrointestinal tract endoscopy
parental consent for participation in the study
Exclusion criteria:
History of allergy to study drug
Severe respiratory disease
Severe cardiovascular disease
uncontrolled diseases
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
144
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
IR.MUI.REC.1394.3.673
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Secondary outcomes
1
Description
Duration of stay in recovery
Timepoint
From recovery admission to recovery discharge
Method of measurement
Watch or clock
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
3
Description
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.
Category
Prevention
4
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Amir Shafa
Street address
Emam Khomeini boulivard
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghyegh Haghjoo
Street address
Hezar Jarib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar jarib street, Azadi square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
fatemejfr1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroayasedeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3626 5773
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3626 5773
Email
behzad_nazem@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only registered symptoms can be shared without mentioning the names of the participants.
When the data will become available and for how long
Access period 8months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Requesting by e-mail
From where data/document is obtainable
The request is sent to the person via e-mail and will be answered after a review within 10 working days
What processes are involved for a request to access data/document
The request is reviewed by the Person responsible for general inquiries and will be answered within ten days after obtaining the consent of the Person responsible for scientific inquiries.