determination and comparison of results of ketamine and apotel infusion pumps for pain control after posterior fusion surgery
Design
clinical trial with control group , with parallel groups , double blinde , randomized
Settings and conduct
background : spinal surgery
location : hazrate rasool akram hospital,operative room and department of the neurosurgery
method : induction of anesthesia with the same drugs and starting the pain pump with the soecified content of the recovery
blind : researcher and department staff and responsible for collecting data by coding instead of writing the drug name
Participants/Inclusion and exclusion criteria
lack of underlying illness
lack of adiiction
age is within the specified range
patient satisfaction
normal body mass index
Intervention groups
control group1:use of ketamin
control group2:use of apotel
Main outcome variables
pain
nausea and vomiting
delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043430N1
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
mohammad ghaemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
ghaemi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-09, 1397/10/19
Expected recruitment end date
2019-04-18, 1398/01/29
Actual recruitment start date
2019-01-19, 1397/10/29
Actual recruitment end date
2019-04-08, 1398/01/19
Trial completion date
2019-04-08, 1398/01/19
Scientific title
A Comparative Study on the Use of Ketamine and Apotel Infusion Pump for the Control of Pain After Posterior Fusion Operations
Public title
" Comparison of Apotel and Ketamine for Pain Control "
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of underlying illness
Lack of addiction
Age is within the specified range
Negative viral markers
Body mass index
A simple random method or a random number table has been used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, without knowing the name of the medicine, is simply aware of the administration of the drug.
The collector and the medical personnel are not aware of the contents because of the code on the pomp.
The researcher does not interfere with the outcome and scoring of pain.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Science., Next to the Tower of Milad., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-01-09, 1397/10/19
Ethics committee reference number
IR.IUMS.FMD.REC1396.9411174024
Health conditions studied
1
Description of health condition studied
Pain after posterior fusion surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score after the end of the injection pump
Timepoint
0,6,12,18,24,48 hours
Method of measurement
The question of the patient himself
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After extubation, the pain pump containing 0.2 mg/kg of ketamine in the operating room was connected to the patients. Then, the pain score was measured by the VAS standard and in case of sever pain , 0.2 mg/kg pethedine was injected and, if continued, pain was controlled with morphine.
Category
Treatment - Drugs
2
Description
Control group: After extubation, the pain pump containing 1gr apotel in the operating room was connected to the patients. Then, the pain score was measured by the VAS standard and in case of sever pain , 0.2 mg/kg pethedine was injected and, if continued, pain was controlled with morphine.