Purpose of study: Evaluating the efficacy and safety of oral low dose ketamine for pediatric Intravenous cannulation.
Design: prospective randomized double blind placebo controlled,Single-center, Phase II trial
Inclusion criteria: children aged 3 to 6 years with no baseline pain who are peroral.
Exclusion criteria: having any medical condition in which procedure is emergent and there is no 20-30 minutes chance to take analgesic; having any contraindication for prescribing ketamine (included but not limited to high blood pressure; high intracranial pressure; high intraocular pressure; Heart failure; Thyroid diseases; Respiratory system instability); the history of taking ketamine by patient in the last 24 hour in this center (in this study); 4. American Society of Anesthesiologists class≥ III; abnormal neurological exam; lack of parental consent; having any condition that makes evaluating pain difficult; Glasgow Coma Scale less than 15. Sample size:70 (35 in each group).
Intervention: in intervention group, ketamine (Intravenous formulation) mixed with orange juice with dose of 3 mg/kg given orally as a single dose. patient in control group take only orange juice. After 20 - 30 minutes intravenous placement is done and the amount of pain in the two groups is measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504251764N3
Registration date:2015-07-06, 1394/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Toktam Faghihi
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tfaghihi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of oral low dose ketamine for pediatric Intravenous cannulation
Public title
Effect of Ketamine for pediatrics pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with no pain at baseline will enter the study؛ also children take part in the study who are able to take the drug orally.
Exclusion criteria: having any medical condition in which procedure is emergent and there is no 20-30 minutes chance to take analgesic; having any contraindication for prescribing ketamine (included but not limited to high blood pressure; high intracranial pressure; high intraocular pressure; Heart failure; Thyroid diseases; Respiratory system instability); the history of taking ketamine by patient in the last 24 hour in this center (in this study); 4. American Society of Anesthesiologists class≥ III; abnormal neurological exam; lack of parental consent; having any condition that makes evaluating pain difficult; Glasgow Coma Scale less than 15.
Age
From 3 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Postal code
141556451
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
9111358004-137896
Health conditions studied
1
Description of health condition studied
pain during Intravenous placement in pediatrics
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain while Intravenous placement in pediatrics
Timepoint
30 minutes after taking oral Ketamine
Method of measurement
Measurement of pain in children ; pain score(Children's Hospital of Eastern Ontario Pain Scale, Visual Analog Scale)
2
Description
Cooperation during catheter insertion
Timepoint
30 minutes after taking the oral ketamine
Method of measurement
I.V Sedation Scale
Secondary outcomes
1
Description
Potential side effects due to use of oral ketamine
Timepoint
first 1 hour and 24 hours after taking of oral ketamine
Method of measurement
Checklist of side effects of ketamine
Intervention groups
1
Description
After obtaining consent from the parents of patients , patients are classified in two groups of intervention and control by
permuted block randomization . Then for each group a questionnaire including demographic informations , age, gender, weight, chief complaint, ASA class, primary diagnosis, receiving concomitant medications, location of Intravenous placement and other required information are recorded. In the intervention group ketamine mixed in orange juice with dose of 3 mg/kg is given to patients orally one dose. after20- 30 minutes Intravenous placement is done and the pain of patients is measured with desired scales during the procedure.
Category
Treatment - Drugs
2
Description
After obtaining consent from the parents of patients , patients are classified in two groups of intervention and control by permuted block randomization . then for each group a questionnaire including demographic informations , age, gender, weight, chief complaint, ASA class, primary diagnosis, Receiving concomitant medications, location of Intravenous placement, duration of procedure, final diagnosis and other required information are recorded. in the control group,patients take only orange juice. after20- 30 minutes iv placement is done and the pain of patients is measured with desired scales during the procedure.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital Medical Center
Full name of responsible person
Mahdi Bagheri(Resident of Clinical Pharmacy)
Street address
No. 62, Doctor Mohammad Gharib Street, Keshavarz Blvd, next to Imam Khomeini hospital,Tehran, Children's Medical Center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Vice chancellor for research,Tehran University of Medical Sciences, Qods Street, 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
Vice chancellor for research,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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Bagheri
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy of Tehran University of Medical Sciences, 16 Azar Street, Enghelab Square, Tehran
City
Tehran
Postal code
Phone
+98 21 3605 4188
Fax
Email
m_mbagheri1367@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Toktam Faghihi
Position
Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Faculty of Pharmacy of Tehran University of Medical Sciences, 16 Azar Street, Enghelab Square, Tehran
City
Tehran
Postal code
Phone
+98 21 3605 4188
Fax
Email
tfaghihi@razi.tums.ac.irtoktamie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Bagheri
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy of Tehran University of Medical Sciences, 16 Azar Street, Enghelab Square, Tehran
City
Tehran
Postal code
Phone
+98 21 3605 4188
Fax
Email
m_mbagheri1367@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)