The goal of the present randomized clinical trial study was to asses and compare effects of Sodium thiopental versus Midazolam-Ketamine on postoperative agitation after pediatric tonsillectomy. Inclusion criteria: children aged between 5 and 15 years candidating tonsillectomy, who were group in class 1 and 2 anesthesia. Exclusion criteria : Inability to intubation, History of use barbiturates. The study was done on children, who had been referred to Valiasr hospital for tonsillectomy
Totally, 50 patients between 5 and 15 years were selected based on criteria and were randomly divided into two 25 patient groups (Nesdonal and Midazolam-Ketamine group)
In the first group nesdonal 5mg/kg/IV, in the second group ketamine1mg/kg and midazolam 0.01 mg/kg, were administered intravenous. level of sedation was evaluated by the Ramsay Sedation Scale postoperative
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205066808N4
Registration date:2014-06-26, 1393/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-26, 1393/04/05
Registrant information
Name
Maryam Tolyat
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 9056
Email address
tolyatm@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sodium thiopental versus Midazolam-Ketamine in postoperative agitation after pediatric tonsillectomy
Public title
effect of Sodium thiopental versus Midazolam-Ketamine in postoperative agitation after pediatric tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aged between 5 and 15 years ; class 1 and 2 anesthesia; Candid of surgery tonsillectomy
Exclusion criteria : Inability to intubation; History use of barbiturates
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Approval date
2013-04-15, 1392/01/26
Ethics committee reference number
772
Health conditions studied
1
Description of health condition studied
tonsillectomy
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
Sedation score
Timepoint
postoperative
Method of measurement
Ramsay Sedation Scale
Secondary outcomes
1
Description
Pulse
Timepoint
Before, during and postoperative
Method of measurement
Pulse oximeter
2
Description
Oxygen saturation of arterial blood
Timepoint
Before, during and postoperative
Method of measurement
Pulse oximeter
Intervention groups
1
Description
nesdonal group : nesdonal 5 mg per kg
Category
Treatment - Drugs
2
Description
midazolam- ketamin group:midazolam1mg per kg and midazolam 0.01 mg per kg intrvenous
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Street address
Valiasr Hospital, Birjand University of Medical Sciences, Birjand, Jonoubi khorasan, Iran
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzaadeh
Street address
Birjand University of Medical Sciences, Ghafarie street, Birjand,Jonoubi khorasan, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
Msc
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafarie street, Birjand,Jonoubi khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 1882 5450
Fax
Email
tolyatm@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
Msc
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 1882 5450
Fax
Email
tolyatm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Malihe Zangouie
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Postal code
Phone
+98 56 1444 3000
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)