Comparison the effect of oral mixture of midazolam and ketamin with oral mixture of meperidine and cholral hydrate in agitation and post operative pain in pediatric patients undergoing tonsillectomy
In this study we aim to compare the effect of oral mixture of midazolam and ketamine with oral mixture of meperidine and chloral hydrate in calmness of pediatrics during going to operation room, emergence agitation following operation ,severity of post operative pain and also complications like nausea and vomiting will be compared too.64 pediatrics patients who will be candidate and have study's criteria will be allocated by simple randomization in the two 32 pediatrics groups. In the group one pediatrics will received oral mixture of midazolam5 mg/kg with ketamine 5mg/kg 30 min before going to operation and in group two, pediatrics will received oral mixture mepeidine 1.5 mg/kg and chloral hydrate50 mg/kg 30 min before going to operation.Then pediatrics calmness during going to operation, postoperative pain and agitation will be recorded and will be compared. Also, complications such as nausea and vomiting will be recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111611662N8
Registration date:2015-12-17, 1394/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-17, 1394/09/26
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral mixture of midazolam and ketamin with oral mixture of meperidine and cholral hydrate in agitation and post operative pain in pediatric patients undergoing tonsillectomy
Public title
Effect of oral mixture of midazolam and ketamin with oral mixture of meperidine and chloral hydrate on calmness and post operative pain in pediatric tonsillectomy surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
64 pediatrics patients who will be candidate for elective tonsillectomy under general anesthesia will be enrolled in this study. Exclusion criteria are: emergency surgery; history of cardiopulmonary disorders; hypersensitivity to study's drugs; liver disease; kidney disease and history of convulsion.
Age
From 3 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Shiraz Medica School Research Ethic Committee
Street address
Shiraz Medical School -Zand Blv
City
Shiarz
Postal code
197871345
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.sums.med.rec.1394.351
Health conditions studied
1
Description of health condition studied
pain following tonsillectomy
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
post operative pain
Timepoint
Every hour during first 6 hours post operation
Method of measurement
Backer-Wong-faces pain scale
2
Description
postoperative agitation
Timepoint
after awakening in recovery room
Method of measurement
according to this scale: 1.Asleep ;2. Awake but comfort ;3.Agitate ; 4.severly agitate and difficult to calm
3
Description
calmness during going to operatin theater
Timepoint
During seperation from parents and going to operation theater
Method of measurement
according to this scale: 1.Full awake-calm ; 2. crying ; 3. violent movement ; 4. Asleep
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
Every one hour during first postoperative 6 hr
Method of measurement
Nausea is defined as urge to vomiting without ejection ofof the contents of the stomach through the mouth, Vomiting is defined asto eject of the contents of the stomach through the mouth, usually in a series of involuntary spasmic movements.
Intervention groups
1
Description
In the group one pediatrics will be received oral mixture midazolam and ketamine mg/kg 30 min before going to operation room.
Category
Treatment - Drugs
2
Description
in the 2nd group pediatrics will be received oral mixture of meperidine mg/kg and chloral hydrate mg/kg 30 min before operation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili training and medical center
Full name of responsible person
Mohamma Ali Sahmeddini
Street address
Khalili Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Fellowship Of Organ Transplantation Anesthesia
Other areas of specialty/work
Street address
Shiraz Anesthesilology and critical care Research center, Namazi Hospital, Namazi Sq.
City
Shiraz
Postal code
1135171937
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)