This study is a double-blind clinical trial in which patients will be randomly divided into three treatment groups.
Settings and conduct
Imam Hossein Children Educational and Medical Center in 1401
Participants/Inclusion and exclusion criteria
incloud criteria: Age between 3 and 10 months Candidate of unilateral cleft lip of both sexes
The first operation is lip cleft
Duration of surgery less than 2 hours
ASA patients have I and II
Parents must complete the study entry consent form
excloud criteria: The surgery lasts more than 2 hours
Hemodynamic changes require therapeutic action
Re-need for topical injection of epinephrine at the site of surgery
Reaction to any of the drugs studied
Intervention groups
Group A combined epinephrine 1200000, 1 cc bupivacaine 0.5% and 0.1 mg / kg dexamethasone to a total volume of 2 cc, and group B combined epinephrine 1200000, 1 cc bupivacaine 0.5% and 0.5 μg / kg dexmedetomidine to a total volume of 2 cc And group C epinephrine
1200000, 1 cc of bupivacaine 0.5% to the total volume of 2 cc in the stand
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220312054261N1
Registration date:2022-04-03, 1401/01/14
Registration timing:prospective
Last update:2022-04-03, 1401/01/14
Update count:0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Iman Reisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3223 9619
Email address
iman.reeisy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding Dexamethasone and Dexmedetomidine to Bupivacaine infiltration on cleft lip surgery pain
Public title
effect of adding Dexamethasone and Dexmedetomidine to Bupivacaine infiltration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 3 and 10 months Candidate of unilateral cleft lip of both sexes
The first operation is lip cleft
Duration of surgery less than 2 hours
ASA patients have I and II
Parents must complete the study entry consent form.
Exclusion criteria:
The surgery lasts more than 2 hours
Hemodynamic changes require therapeutic action
Re-need for topical injection of epinephrine at the site of surgery
Reaction to any of the drugs studied
Age
From 3 months old to 10 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The lottery is used for randomization and is adjusted based on the patients' national code number. The national number of patients is prepared and each number is written on a piece of paper, then drawn (one of the nurses in the study is asked to shuffle the sheets in a cup and one by one The first 25 people will be in the first group, the second 25 people will be in the second group and the rest of the patients will be in the third group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is double-blind. The main researcher prepares the drugs in the appropriate dose in a specific syringe and the surgeon injects the drug into the site of the cleft lip without knowing the content of the drug, and the person who records the parameters and Collects does not know the type of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Using the scale of face, legs, activity, crying and comfort, which is one of the most common and widely used scales of observational-behavioral pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: epinephrine 1200000, 1 cc bupivacaine 0.5% and 0.1 mg / kg dexamethasone with a total volume of 2 cc- Drops of dexamethasone ampoules 8 mg / 2 ml [Raha Pharmacy]- bupivacaine -agutant vial 0.5% 20 ml [Exir Pharmacy]
Category
Treatment - Drugs
2
Description
Intervention group: epinephrine 1200000, 1 cc of bupivacaine 0.5% and 0.5 μg / kg of dexmedetomidine with a total volume of 2 cc - Madonex vial 200 micrograms / 2 ml [Exir Pharmacy]- Epinephrine DP 0.01% 10 ml ampoule[Drug Distributor - Factory]
Category
Treatment - Drugs
3
Description
Intervention group: epinephrine 1200000, 1 cc of bupivacaine 0.5% to a total volume of 2 cc
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Children Educational and Medical Center
Full name of responsible person
Sedighe Shahhosseini
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Web page address
http://www.ehuch.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedighe Shahhosseini
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
10
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
Esfahan University of Medical Sciences
Full name of responsible person
Sedighe Shahhosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
003133866266
Email
nasrin20ir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Reisi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3128 5696
Email
Iman.reeisy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Raisi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
003131285696
Email
Iman.reeisy@gmail.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