Comparing intramuscular and intranasal Ketamin in pain reduction of pediatrics between 2 and 15 years during procedural sedation in emergency department
Object: Comparing the effect of intrannasal Ketamin with intramuscular Ketamin in decreasing the pain in pediatric patients.
Methods and Material: The above study is a double blind and randomized clinical trial which will be accomplished on 60 children aging 2 to 15 years, with the same physical conditions and same circumstances admitted in Tehran Hazrate Rasoul Hospital. The patients admitted according to the criterion of the study will be randomly divided in one of two groups of the study;
Interventions: It means 30 patients will be considered for each group.For group one, one to two milligrams per kilogram of intramuscular Ketamin and for the second group one to two milligrams per kilogram of intranasal Ketamin will be administered. The children will be evaluated before, during and after drug administration using pain evaluation scales for children and also the level of their satisfaction and the results will be documented.
Inclusion Criteria: Necessity to perform different types of procedures including repair of lacerations in different sizes and in every region of body and also types of reductions in emergency department; Level of consciousness more than 15 in GCS format; Age between 2 and 15; Not suffering of any mental disorders; Consent of the patient for the procedures.
Exclusion Criteria: Any past history of surgery on trachea or tracheal stenosis; Active lung infection; Intake of large amount of food during three hours before procedure; Cardiovascular diseases including angina and heart failure and hypertension; Trauma or head injury resulting in lowering level of consciousness or vomiting; Mass in CNS or hydrocephalus; Not well controlled seizure ; Glaucoma or Acute globe injury; Psychosis and Porphiria and Thyroid Disease and treatment with drugs of thyroid disease; Cardiac complications due to Ketamin administration; Not having consent of parents and guardians or the patient himself.
Primary Outcome Value: evaluation of pain in different intervals: before, during and after drug administration using pediatric pain scales.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052417825N1
Registration date:2014-07-06, 1393/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-06, 1393/04/15
Registrant information
Name
Elham Sheikh aboumasoudi
Name of organization / entity
Emegency medicine
Country
Iran (Islamic Republic of)
Phone
+98 31 1667 3828
Email address
elhamaboumasoudi82@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tehran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing intramuscular and intranasal Ketamin in pain reduction of pediatrics between 2 and 15 years during procedural sedation in emergency department
Public title
Comparing intramuscular and intranasal Ketamin in procedural sedation of pediatrics between 2 and 15 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Necessity to perform different types of procedures including repair of lacerations in different sizes and in every region of body and also types of reductions in emergency department; Level of consciousness more than 15 in GCS format; Age between 2 and 15; Not suffering of any mental disorders; Consent of the patient for the procedures.
Exclusion Criteria: Any past history of surgery on trachea or tracheal stenosis; Active lung infection; Intake of large amount of food during three hours before procedure; Cardiovascular diseases including angina and heart failure and hypertension; Trauma or head injury resulting in lowering level of consciousness or vomiting; Mass in CNS or hydrocephalus; Not well controlled seizure ; Glaucoma or Acute globe injury; Psychosis and Porphiria and Thyroid Disease and treatment with drugs of thyroid disease; Cardiac complications due to Ketamin administration; Not having consent of parents and guardians or the patient himself.
Age
From 2 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tehran University of Medical Sciences
Street address
Ghods street- Keshavarz blvd- Tehran
City
Tehran
Postal code
Approval date
2012-10-28, 1391/08/07
Ethics committee reference number
1815/ 130 /د/91
Health conditions studied
1
Description of health condition studied
ٍٍExtremity Trauma
ICD-10 code
XIII
ICD-10 code description
Musculoskeletal System and Connective Tissue Diseases
Primary outcomes
1
Description
Pain Severity
Timepoint
Before, during and after drug administration
Method of measurement
Administration of Visual Analogue Scale and asking the patient to determine the picture representative of pain severity
Secondary outcomes
1
Description
changes in Vital Signs and Side effects
Timepoint
Before, during and after drug administration
Method of measurement
According to history and physical examination
Intervention groups
1
Description
Intervention Group: Nasal spray of 1-2 mg/kg of Ketamin
Category
Treatment - Drugs
2
Description
Control Group: Intramuscular injection of 1-2 mg/kg Ketamin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Hazrate Rasool (S) Educational-Therapeutic Centre
Full name of responsible person
Saieed Abbasi, Medical Doctor
Street address
Emergency Department, Hazrate Rasool Hospital, Niyayesh street, Sattarkhan, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh, Medical Doctor
Street address
Tehran University of Medical Sciences, Enghelab St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of 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
Iran University of Medical Sciences
Full name of responsible person
Saeed Abbasi, Medical Doctor
Position
Assistant Professor
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Niayesh St. Satarkhan st.
City
Tehran
Postal code
Phone
+98 21 6535 2022
Fax
Email
saieedabbasi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeed Abbasi, Medical Doctor
Position
Assistant Professor
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Nyayesh St. Satarkhan st.
City
Tehran
Postal code
Phone
+98 21 6535 2022
Fax
Email
saieedabbasi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Sheikh Aboumasoudi, Medical Doctor
Position
Medical Doctor
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan st.
City
Tehran
Postal code
Phone
+98 21 6535 2022
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)