Protocol summary

Study aim
Comparison of pain and agitation and nausea and vomiting and time and dose of analgesic in rupivacaine plus dexamethasone and rupivacaine plus ketamine
Design
In this double-blind clinical trial study, 5 patients, aged 2 to 4 years, referred to Amir Kabir Hospital, Arak, were diagnosed with tonsillectomy and met inclusion criteria after obtaining informed consent. Patients under study were divided into two groups: dexamethasone and ketamine.
Settings and conduct
Given the double-blindness, only the primary investigator is aware of the groups and drugs used in this study, and patients and interns are responsible for collecting data from the groups and drugs used. This study was performed in Amirkabir hospital in Arak in 1398 in which all patients underwent tracheal anesthesia after entering the operating room. Then, the interventions are performed by the surgeon and their consequences are statistically analyzed.The extent of pain is determined by VAS ruler at 15, 30 and 2, 4, 8, 16, 24 hours, Agitation was measured by the Riker Sedation-Agitation scale at 15, 30, and 2, 4, 8, 16, and 24 minutes after surgery.
Participants/Inclusion and exclusion criteria
Children between the ages of 3 and 5 years are candidates for elective tonsillectomy in the absence of underlying disease and no history of motion sickness. If surgery lasts more than 2 hours and bleeding exceeds 10 cc / kg, the study will be excluded.
Intervention groups
In the first group, the surgeon delivered 2 cc of 0.5% ropivacaine solution plus dexamethasone 0.5 mg / kg (maximum 1 mg) with distilled water to CC 10 and in the second group 2 cc of ropivacaine solution 0.5% plus ketamine 0.5 mg / kg. With the help of distilled water, it reaches CC 10 and is injected into the peritonsillar fossa by the surgeon so that the injection is only in the sub mucus area. 5cm injection is given on each side.
Main outcome variables
Pain; Agitation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191022045200N1
Registration date: 2019-10-28, 1398/08/06
Registration timing: retrospective

Last update: 2019-10-28, 1398/08/06
Update count: 0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Fatemeh Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3774 4933
Email address
s_zeiho@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-09-22, 1398/06/31
Scientific title
Comparison of addition of ketamine and dexamethasone to ropivacaine in peritonsillar infiltration to reduce postoperative pain
Public title
The effect of dexamethasone and ketamine on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 1 to 4 years old candidate for elective tonsillectomy Absence of underlying cardiovascular, respiratory, kidney, liver and brain diseases No history of motion sickness
Exclusion criteria:
Surgery lasts more than 4 hours Bleeding action greater than 10 cc / kg
Age
From 3 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 92
Actual sample size reached: 92
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 5 patients, aged 4-5 years, referred to Amir Kabir Hospital in Arak, were diagnosed with tonsillectomy and met inclusion criteria after obtaining informed consent. Patients were then randomly divided into two groups of dexamethasone plus bupivacaine and ketamine plus bupivacaine.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness Due to the double blindness of the study, only the relevant expert in this study is aware of the type of study and study groups, while patients are not aware of the type of drug being used. Also, the intern who is responsible for the design of the checklist is not aware of the groups based on the injectable drug and only identifies the groups based on A and B and fills the checklists accordingly.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.ARAKMU.REC.1397.062

Health conditions studied

1

Description of health condition studied
Tonsillectomy
ICD-10 code
J35.03
ICD-10 code description
Chronic tonsillitis and adenoiditis

Primary outcomes

1

Description
Pain score on the Visual Analogue Scale
Timepoint
Minutes 15, 30 and 2, 4, 8, 16, 24 hours after surgery
Method of measurement
Visual Analogue Scale ruler

Secondary outcomes

1

Description
Patient Agitation rate
Timepoint
Minutes 15, 30 and 2, 4, 8, 16, 24 hours after surgery
Method of measurement
Riker Sedation-Agitation scale

Intervention groups

1

Description
First Intervention group: 2 cc of ropivacaine 0.5% plus dexamethasone 0.5 mg / kg (maximum 1 mg) with distilled water delivered to CC 10 and injected into the peritonsillar fossa by the surgeon so that the injection was only in the sub mucus area. 5cm injection is given on each side.
Category
Treatment - Drugs

2

Description
Second Intervention group: CC 2 of 0.5% ropivacaine solution plus 0.5 mg / kg ketamine with distilled water is delivered to CC 10 and injected into the peritonsillar fossa by the surgeon so that the injection is only in the sub mucus area. 5cm injection is given on each side.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان امیرکبیر اراک
Full name of responsible person
فاطمه حسینی
Street address
Amirkabir Hospital, Parastar Sq., Shiroudi St.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3313 4715
Email
research@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
علیرضا کمالی
Street address
Payambar-e-azam Complex, Arak Univercity of Medical science
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
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
Fatemeh Hoseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 68, Fourteen Alley, Somayeh Blv, Moallem Sq.
City
Qom
Province
Ghoum
Postal code
3715694439
Phone
+98 25 3774 4933
Email
S_zeiho@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Hoseini
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 68, Fourteen Alley, Somayeh Blv, Moallem Sq.
City
Qom
Province
Ghoum
Postal code
3715694439
Phone
+98 25 3774 4933
Email
S_zeiho@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Hoseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 68, Fourteen Alley, Somayeh Blv, Moallem Sq.
City
Qom
Province
Ghoum
Postal code
3715694439
Phone
+98 25 3774 4933
Email
S_zeiho@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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