Protocol summary

Summary
ketamine is used as analgesic for performing procedures in emergency departments especially for children. Vomiting is one the most common adverse effects of ketamine injection. The goal of this study was to determine the effect of ondansetron on ketamine related vomiting in children. Children from 6months to 10years who will come to emergency deparment of Imam or Shariati hospital need procedural sedation analgesia, will randomly assigned to ketamine or ketamine plus ondansetron groups. Patients would exclude from the study, if they had any of exclusion criteria, such as allergy to ketamine or ondansetron, seizure, airway disease, head trauma, uncontrolled high blood pressure and vomiting before starting the process associated with other diseases, especially head trauma. Sample size determined at least 60 children in each groups, means totally 120 patients. The first group will receive 4 mg /kg ketamine (intramuscular) and the second group will receive the same dose of ketamine plus ondansetron (0.1 mg /kg, up to 2 mg) in the same syringe. Level of sedation, vital signs including pulse rate and SpO2 and side effects especially nausea and vomiting will record during procedure, through recovery period and 4 hours after completion of the procedure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201301189162N7
Registration date: 2015-11-30, 1394/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-30, 1394/09/09
Registrant information
Name
Amir Nejati
Name of organization / entity
Tehran University of Medical Sciences, Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2240
Email address
a-nejati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ondansetron on the Incidence of Vomiting Associated With Ketamine Sedation in Children: A half-Blind Randomized,Controlled Trial
Public title
ondansetron for reducing Ketamine related vomiting in children
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria are: allergy to ketamine or ondansetron, seizure, air way disease, head trauma, uncontrolled high blood pressure and vomiting associated with other diseases.children (6 months to 10 years) who will referre to emergency department of Imam or Shariati hospitals will be included.
Age
From 6 months old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University Of Medical Science
Street address
Enghelab Square
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93/د/130/1113

Health conditions studied

1

Description of health condition studied
nasea and vomitting
ICD-10 code
R11
ICD-10 code description
تهوع و استفراغ

Primary outcomes

1

Description
vomitting
Timepoint
before procedure/during procedure/after discharge
Method of measurement
with quastion form

Secondary outcomes

1

Description
Pulse Rate
Timepoint
Continuously during procedure time
Method of measurement
Pulse Oximetry

2

Description
Saturation of peripheral O2 (SpO2)
Timepoint
Continuously during procedure time
Method of measurement
Pulse Oximetry

3

Description
Other Side effects like: Seizure, Shivering,...
Timepoint
In Recovery Period
Method of measurement
Observation

Intervention groups

1

Description
Control Group: Intramuscular injection of Ketamin 4 mg/kg
Category
Treatment - Drugs

2

Description
Intervention Group: Intramuscular injection of Ketamine 4 mg/kg + Ondansetron 0.1 mg/kg (max 2mg) in the same syringe
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Hamideh Akbari
Street address
North Kargar Street
City
Tehran

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hamideh Akbari
Street address
Bagherkhan Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
University Research Manager
Street address
6th Floor, Central Building, Toos Ave, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Emam Khomeyni Hospital
Full name of responsible person
Hamideh Akbari
Position
residence of emergency medical science
Other areas of specialty/work
Street address
Enghelab Square,Gharib Street
City
Tehran
Postal code
Phone
+98 21 6643 7542
Fax
Email
hamideh.akbari1079@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Emam Khomeyni Hospital
Full name of responsible person
Amir Nejati
Position
emergency medicine professor
Other areas of specialty/work
Street address
Enghelab square ,Gharib hospital
City
Tehran
Postal code
Phone
+98 21 6680 2838
Fax
Email
nejati.am@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Emam Khomeyni Hospital
Full name of responsible person
Hamideh Akbari
Position
residence of emergency medicine
Other areas of specialty/work
Street address
Enghelab square,Gharib street
City
Tehran
Postal code
Phone
+98 21 6643 7542
Fax
Email
hamideh.akbari1079@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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