Comparison of frequency of sore throat after jaw surgery with and without pharyngeal packing
Design
The study is a single-blind clinical trial on 60 patients aged 18 - 40 years old with mallampati class of I-II who are candidates for jaw surgery. Convenience sampling will be used and randomization will be done using random numbers table.
Settings and conduct
The study will be done in Shafa and Bahnoar hospital in Kerman. The study is a single-blind clinical trial. Patients are not aware of the group they are assigned to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidates of jaw surgery; Mallampati class of II - I.
Exclusion: Lack of participation consent; Prolonged laryngoscopy (more than 15 seconds or more than once); History of a sore throat before the surgery
Intervention groups
Intervention group: pharyngeal packing with a gauze soaked with 10cc normal saline solution. Control group: no packing.
Main outcome variables
Sore throat severity and related symptoms (Odynophagia, cough, nausea, vomitting)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210730052019N1
Registration date:2021-08-25, 1400/06/03
Registration timing:registered_while_recruiting
Last update:2021-08-25, 1400/06/03
Update count:0
Registration date
2021-08-25, 1400/06/03
Registrant information
Name
Mehran Ilaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 7779
Email address
mehran-ilaghi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of frequency of sore throat after jaw surgery with and without pharyngeal packing
Public title
Effect of pharyngeal packing on sore throat after jaw surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates of jaw surgery
Mallampati class of II - I
Exclusion criteria:
Lack of participation consent
Prolonged laryngoscopy (more than 15 seconds or more than once)
History of sore throat before the surgery
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Since we need an equal number of participants in each group, we will use the block randomization method using Random Allocation Software. The software will randomly assign 60 patient codes to either intervention or control group. In order of entering the study and recruit, patients will be assigned to codes 1 to 60 and regarding the output of the software, the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a single-blind randomized clinical trial in which the patients are not aware of the group they are assigned to. Caretakers, investigators, and data analyst are aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kerman University of Medical Sciences
Street address
Haftbagh-Alavi highway, Kerman University of medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.KMU.AH.REC.1400.096
Health conditions studied
1
Description of health condition studied
anesthesia , Jaw surgery
ICD-10 code
M27.9
ICD-10 code description
Disease of jaws, unspecified
Primary outcomes
1
Description
Severity of sore throat
Timepoint
2, 6, 12, 24 hours after surgery
Method of measurement
visual analogue scale
2
Description
Nausea
Timepoint
2, 6, 12, 24 hours after surgery
Method of measurement
Data gathering sheet (Subjective interview with patient)
3
Description
Vomitting
Timepoint
2, 6, 12, 24 hours after surgery
Method of measurement
Data gathering sheet (Subjective interview with patient)
4
Description
Cough
Timepoint
2, 6, 12, 24 hours after surgery
Method of measurement
Data gathering sheet (Subjective interview with patient)
5
Description
Odynophagia
Timepoint
2, 6, 12, 24 hours after surgery
Method of measurement
Data gathering sheet (Subjective interview with patient)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group a gauze soaked with 10 cc normal saline solution for pharyngeal packing.
Category
Prevention
2
Description
Control group: Despite the intervention group, in control group no pharyngeal packing will be used.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Roohollah Movahedinia
Street address
Shafa street, Shafa hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
2
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Roohollah Movahedi
Street address
Valiasr crossroad, Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Bh.hospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Davood Kalantar
Street address
Haftbagh alavi highway, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
0
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
Kerman University of Medical Sciences
Full name of responsible person
Roohollah Movahedinia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shafa street, shafa hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drmovahedi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roohollah Movahedinia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shafa street, shafa hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drmovahedi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roohollah Movahedinia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shafa street, shafa hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drmovahedi@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