To compare the post-tonsillectomy pain using Succinylcholine versus Cisatracuriumin in children and adolescents under 18 years old
Design
In this randomized, double blind clinical trial, 84 patients who were candidate for a tonsillectomy and eligible for inclusion in the study were selected. Participants were randomly divided into 2 medicine intervention groups.
Settings and conduct
Since the adoption of the proposal, patients who were candidates for a tonsillectomy, were randomly divided into two groups of Succinylcholine and Cisatracurium.The randomization method was Block Randomization. The procedure and anesthesia were the same in the two groups. surgeries were conducted in educational hospitals under supervision of Shiraz University of Medical Sciences. All the surgeries were performed by the performer. Outcome of pain were recorded by patients or their parents within 7 days after surgery.The assistant co-worker then collected the information and delivered it to the statistician. The statistician did not know about the procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 3 - 18 years old children and adolescents; no physical or psychological problems; living nearby the hospital; at least one of the parents should have high school education. Exclusion criteria: congenital syndromes; immunodeficiency; any systemic or psychiatric diseases; family history of pseudocholinesterase deficiency
Intervention groups
One group received Succinylcholine 1.5 mg/kg and the other one Cisatracurium 0.15 mg/kg, as muscle relaxant in tonsillectomy.
Main outcome variables
post-tonsillectomy pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131123015496N20
Registration date:2018-06-15, 1397/03/25
Registration timing:retrospective
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2014-08-20, 1393/05/29
Actual recruitment start date
2014-06-21, 1393/03/31
Actual recruitment end date
2014-08-20, 1393/05/29
Trial completion date
empty
Scientific title
Comparison of Post-Tonsillectomy Pain using Succinylcholine versus Cisatracurium
Public title
Comparison of Post-Tonsillectomy Pain using Succinylcholine versus Cisatracurium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3 - 18 years old children and adolescents; no physical or psychological problems; living nearby the hospital; at least one of the parents should have high school education.
Exclusion criteria:
immunodeficiency, congenital syndromes; any systemic or psychiatric diseases; family history of pseudocholinesterase deficiency
Age
From 3 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with one person and random numbers 0 to 9.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, data analyzer and those who evaluate the outcome, that is, the participants or their parents were unaware of the type of material used in practice.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2013-09-25, 1392/07/03
Ethics committee reference number
CT-P-92-5085
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.1, J35
ICD-10 code description
Hypertrophy of tonsils, Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
Pain score intensity after tonsillectomy
Timepoint
1, 2, 4 Hours after tonsillectomy and then four times a day; before breakfast, lunch, dinner and also before sleep for 7 days after surgery
Method of measurement
Faces Pain Scale (FPS-R)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: received Succinylcholine (S.choline) 1.5 mg/kg t Cisatracurium 0.15 mg/kg, as muscle relaxant in operation room.
Category
Treatment - Drugs
2
Description
Intervention group 2: received Cisatracurium 0.15 mg/kg, as muscle relaxant in operation room.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Dr. Mohammad Faramarzi
Street address
Next to National Garden, Hafez Street
City
Shiraz
Province
Fars
Postal code
71456-83769
Phone
+98 71 3228 8064
Email
dhospital@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Vice Chancellor for Research ,Shiraz University of Medical Sciences-7th floor-Central Building of Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sareh Roosta
Position
Statistical consultant
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
خیابان خلیلی، بیمارستان خلیلی، گروه گوش و حلق و بینی
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
Roosta.Sareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faramarzi
Position
Associate Professor of Otolaryngology
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
Faramarzi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sareh Roosta
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
Roosta.Sareh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD