Comparison of Peritonsillar injection of mixture of Dexmedetomidine- Ropivacaine and tramadol - Ropivacaine in postoperative pain control and sedation after tonsillectomy under general anesthesia
Comparison of Peritonsillar injection of mixture of Dexmedetomidine- Ropivacaine and tramadol - Ropivacaine in postoperative pain control and sedation after tonsillectomy under general anesthesia
Design
The study will be double blind and clinical trial.99 patients will be randomly divide into 3 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients with tonsillectomy surgery under general anesthesia in Valiasr hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidate for tonsillectomy, no metabolic glandular disease, no coagulation disease, no mental retardation, absence of peritonsillar, absence of hypertension, absence of psychotic disorder, absence of chronic pain
Exclusion criteria:Dissatisfaction with the patient or parents' own surgery
Intervention groups
Dexmedetomidine and Ropivacaine group: 5 millilitre of a solution containing Ropivacaine 0.25% and 1 μg / kg of dexmedetomidine will be injected as a peritonsillar. (Dexmedetomidine made by Elixir Company - Iran)
Tramadol and Ropivacaine group: 5 millilitre of solution containing Ropivacaine 0.25% and 2 mg per kg of tramadol (manufactured by Caspian Tamin Iran - Rasht) will be injected as a peritonsilla.
Placebo and Ropivacaine group: 5 millilitre of 25% Ropivacaine solution with normal saline will be injected as a peritonsilla.
Main outcome variables
Sedation, pain, total dose of narcotics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N163
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Peritonsillar injection of mixture of Dexmedetomidine- Ropivacaine and tramadol - Ropivacaine in postoperative pain control and sedation after tonsillectomy under general anesthesia
Public title
Comparison of Peritonsillar injection of mixture of Dexmedetomidine- Ropivacaine and tramadol - Ropivacaine in postoperative pain control and sedation after tonsillectomy under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for tonsillectomy
No metabolic glandular disease
No coagulation disease
No mental retardation
Absence of peritonsillar abscess
Absence of hypertension
Absence of psychotic disorder
Absence of chronic pain
Exclusion criteria:
Dissatisfaction with the patient or parents' own surgery
Age
From 3 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 3 groups A and B and C. In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In terms of patient blindness, the complementary intern does not know the groupings, and general anesthesia and drug injections are performed by an anesthesiologist.
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern. Also, the patients do not know about their group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.ARAKMU.REC.1400.040
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J03.9
ICD-10 code description
Acute tonsillitis, unspecified
Primary outcomes
1
Description
Sedation
Timepoint
5 minutes, 15 minutes, 30 minutes, 1, 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Wilson sedation scale
2
Description
Pain
Timepoint
At 5 minutes, 15 minutes, 30 minutes, 1, 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Oucher scale
3
Description
Total dose of narcotics
Timepoint
24 hours after surgery
Method of measurement
Hospital file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: 5 millilitre of a solution containing Ropivacaine 0.25% and 1 μg / kg of dexmedetomidine will be injected as a peritonsillar. (Dexmedetomidine made by Elixir Company - Iran)
Category
Treatment - Drugs
2
Description
Intervention group2: 5 millilitre of solution containing Ropivacaine 0.25% and 2 mg per kg of tramadol (manufactured by Caspian Tamin Iran - Rasht) will be injected as a peritonsilla.
Category
Treatment - Drugs
3
Description
Control group: 5 millilitre of 25% Ropivacaine solution with normal saline will be injected as a peritonsilla.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeel Moshiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street