Determination of the incidence of vomiting in children receiving ketamine.
Determination of the relationship between the dose of ketamine and vomiting
Determination of the relationship between the administration of ketamine and vomiting
Design
Clinical trials without control groups, community-based and action-oriented, non-randomized, four groups with different doses
Settings and conduct
some previous studies reported important adverse events associated with ketamine such as hypoxia, laryngospasm, apnea, vomiting, and emergency reactions. Therefore, we evaluated doses of Ketamine associated vomiting (KAV) in children require sedation, who were referred for diagnostic or treatment services in Ahvaz golestan hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who require sedation for therapeutic or diagnostic process (reduction of fractures, CT scan, stitches, etc.) aged between 4 months to 13 years
Exclusion criteria: patients less than 3 months and more than 13 years patients who had vomiting before sedation patients who did not receive single-dose medication patients who suspected increased ICP asthma or previous adverse reaction to ketamine cardiovascular diseases or hypertension airway tract infections porphyria
Intervention groups
Patients in first group will receive ketamine via intravenous with dosage of 1 mg/kg
Patients in Second group will receive ketamine via intravenous with dosage of 2 mg/kg
Patients in Third group will receive ketamine via intramuscular with dosage of 3 mg/kg
Patients in Fourth group will receive ketamine via intramuscular with dosage of 5 mg/kg
Main outcome variables
vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151114025027N6
Registration date:2018-04-12, 1397/01/23
Registration timing:prospective
Last update:2018-04-12, 1397/01/23
Update count:0
Registration date
2018-04-12, 1397/01/23
Registrant information
Name
Mohammadreza Maleki Varaki
Name of organization / entity
Ahvaz Judishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
maleki-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the association of various ketamine doses with vomiting in children requiring sedation in the emergency department
Public title
Ketamine associated vomiting in children require sedation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who require sedation for therapeutic or diagnostic process (reduction of fractures, CT scan, stitches, etc.)
aged between 4 months to 13 years
Exclusion criteria:
patients less than 3 months and more than 13 years
patients who had vomiting before sedation
patients who did not receive single-dose medication
patients who suspected increased ICP
asthma or previous adverse reaction to ketamine
cardiovascular diseases or hypertension
airway tract infections
porphyria
Age
From 4 months old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation sequence was determined from a computer-generated, random-number table, assigning patients in to two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2014-03-01, 1392/12/10
Ethics committee reference number
ajums.REC.1392.346
Health conditions studied
1
Description of health condition studied
Vomiting
ICD-10 code
R11.1
ICD-10 code description
Vomiting
Primary outcomes
1
Description
vomiting
Timepoint
2 hours after injection
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Patients in first group will receive ketamine via intravenous with dosage of 1 mg/kg
Category
Other
2
Description
Intervention group: Patients in Second group will receive ketamine via intravenous with dosage of 2 mg/kg
Category
Other
3
Description
Intervention group: Patients in Third group will receive ketamine via intramuscular with dosage of 3 mg/kg
Category
Other
4
Description
Intervention group: Patients in Fourth group will receive ketamine via intramuscular with dosage of 5 mg/kg