Study and compare two different doses of magnesium sulfate in decreasing pain and agitation of children after tonsillectomy
Design
It is a double-blinded randomized clinical trial
sampling will be done among children referred for tonsillectomy aged between 3 to 15 years old after receiving written consent and explaining the purpose of the study.
patients will be randomly divided into 3 groups(each group 40 patients) using random allocation software consisting of one control group and two intervention groups
Settings and conduct
pain after tonsillectomy is a big problem because it affects the time of recovery.
this study is a double-blinded randomized clinical trial that takes place in the fall of 1400 in Vali-Asr hospital.
the control group receives the placebo.
The first and second intervention groups receive 2 different doses of magnesium sulfate respectively.
after extubation, measurement of pain and agitation will be performed by uninformed personnel in 5,10,15,30 minutes and then after 1,2,6 hours based on Ricker-sedation-agitation score and FLACC score.
preparation of medication and will be performed and labeld as A,B,C by researchers and will be given to OR personel who has no idea about labels meaning.
As above,Statistical analyzer analyzes the data uniformedly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
consent of patient and parents
Aged between 3 to 15
need to do tonsillectomy
ASA class I II II
Exclusion criteria:
Unwillingness to participate in the study
ASA class IV
anatomical abnormalities in airway
reoperation due to bleeding
difficult intubation
History of cardiology, renal, respiratory diseases and MG
Intervention groups
This study includes 3 groups. first one is the control group. control group receives placebo. intervention groups receive two different doses of magnesium sulfate.
Main outcome variables
decrease in pain post-tonsillectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053130N1
Registration date:2021-12-11, 1400/09/20
Registration timing:registered_while_recruiting
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Mohammad reza Malekmotiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 3878
Email address
rezamalekmotiei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2021-12-28, 1400/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study and compare two different doses of magnesium sulfate in decreasing pain and agitation of children after tonsillectomy
Public title
effect of magnesium sulfate on pain and agitation after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
consent of patient and parentsASA class I II II
need to do tonsillectomy
ASA class I II II
Exclusion criteria:
Unwillingness to participate in study
ASA class IV
anatomical abnormalities in airway
reoperation due to bleeding
difficult intubation
History of cardiology,renal,respiratory diseases
History of MG
Age
From 3 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
After generating random block sequences by Random Allocation Software version 1.0.0, the sequences in each block will be placed in numbered envelopes. for each group of patients, we randomly select one of the blocks, the sequences in each block will be used to assign individuals to one of the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
preparation of medication and placebo will be performed and labeld as A,B,C by researchers and will be given to OR personel who has no idea about labels meaning. researchers have no role in giving the medication and measuring the outcome.
As above,Statistical analyzer will analyze the data without the knowledge that each group receive which medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of fasa University of Medical Sciences
Street address
ebne sina square fasa fars
City
fasa
Province
Fars
Postal code
۸۶۶۸۸ - ۷۴۶۱۶
Approval date
2021-11-21, 1400/08/30
Ethics committee reference number
IR.FUMS.REC.1400.090
Health conditions studied
1
Description of health condition studied
pain and agitation after tonsillectomy in children
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
pain
Timepoint
5 minutes after extubation/10 minutes after extubation/15 minutes after extubation/30 minutes after extubation/1hour after extubation/2 hour after extubation/6 hour after extubation/
Method of measurement
FLACC score for pain
Secondary outcomes
1
Description
agitation
Timepoint
5 minutes after extubation/10 minutes after extubation/15 minutes after extubation/30 minutes after extubation/1hour after extubation/2 hour after extubation/6 hour after extubation/
Method of measurement
Ricker-sedation-agitation score
Intervention groups
1
Description
Control group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.first group as control group will receive no further medication but placebo with same administration method of magnesium sulfate.
Category
Placebo
2
Description
first Intervention group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.then the will receive 30 mg/kg mg sulfate as loading dose fallowed by 10mg/kg/hr for 1 hour as maintenance dose
Category
Treatment - Drugs
3
Description
second Intervention group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.then the will receive 40 mg/kg mg sulfate as loading dose fallowed by 10mg/kg/hr for 1 hour as maintenance dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali asr fasa hospital ,FASA
Full name of responsible person
Mohammad Reza Malek Motiei
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
۸۶۶۸۸ - ۷۴۶۱۶
Phone
+98 71 5335 0994
Email
Info@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mojtaba Farjam
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
۸۶۶۸۸ - ۷۴۶۱۶
Phone
+98 71 5335 0995
Email
Info@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mohammad Reza Malek Motiei
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
۸۶۶۸۸ - ۷۴۶۱۶
Phone
+98 71 5335 0994
Email
Info@fums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sedighe Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
۸۶۶۸۸ - ۷۴۶۱۶
Phone
+98 71 5335 0994
Email
Ahmadis@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mohammad Reza Malek Motiei
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
۸۶۶۸۸ - ۷۴۶۱۶
Phone
+98 71 5335 0994
Email
Rezamalekmotiei@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