1- Evaluation and comparison of severity of postoperative pain in case (ropivacaine) and control (normal saline) groups.
2- Evaluation and comparison of postoperative hemorrhage in case (ropivacaine) and control (normal saline) groups.
3- Evaluation and comparison of the starting time of postoperative oral nutrition in case (ropivacaine) and control (normal saline) groups.
Design
(A one-blind, randomized clinical trial with a control group, and parallel groups)
Settings and conduct
50 children under the age of 15 years with tonsillar hypertrophy referring to Tabriz Children Hospital for tonsillectomy were randomly divided into two groups of 25 cases (ropivacaine) and 25 controls (normal saline). Patients, clinical caregivers, and data analyst will not be aware of grouping.
Participants/Inclusion and exclusion criteria
50 children under the age of 15 years with tonsillar hypertrophy referring to Tabriz Children Hospital for Tonsillectomy will be included in the study after obtaining informed consent from their parents. Children under the supervision of a specialist will undergo tonsillectomy with anesthesia class 1 and 2. Children who have an anesthetic class of more than 2 or have more than an hour of surgery duration, or suffering from post-operative airway complications will be excluded.
Intervention groups
Case group (Ropivacaine): Ropivacaine 0.5% immediately after intubation as well as at the end of the surgery will be administered in the form of a puff on each tonsil.
Control group: Normal saline immediately after intubation as well as at the end of the surgery will be administered in the form of a puff on each tonsil.
Main outcome variables
Pain intensity; prevalence of bleeding; time of onset of postoperative oral nutrition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100527004041N16
Registration date:2019-05-08, 1398/02/18
Registration timing:retrospective
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-03-11, 1397/12/20
Trial completion date
2019-05-21, 1398/02/31
Scientific title
The Effect of Topical Ropivacaine Spray on Relief of Post-Tonsillectomy Pain in Children
Public title
The Effect of Ropivacaine in Tonsillectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 15 years of age
Suffering from Tonsillar hypertrophy
Referring to Tabriz Children Hospital for tonsillectomy
Exclusion criteria:
The anesthetic class of more than 2
Duration of surgery of more than an hour
Airways complications after surgery
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the samples was done by using online software available at www.stat.vbc.ca/nrolin/statssize/bz.html.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients, clinical caregivers, and data analyzers will not aware of grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1053
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
Pain severity
Timepoint
One hour after recovery
Method of measurement
By Visual Analogue Scales
2
Description
Incidence of bleeding
Timepoint
One hour after recovery
Method of measurement
View and questionnaire
3
Description
Oral feeding initiation time
Timepoint
One hour after recovery, until the discharge
Method of measurement
View and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 0.5% ropivacaine (ropivacaine hydrochloride, 5 mg/ml; MOLTENI farmaceutici, Italy) spray immediately after intubation as well as at the end of the surgery will be administered in the form of a puff (0.1 ml) on the surface of each tonsil.
Category
Other
2
Description
Control group: A normal saline spray immediately after intubation as well as at the end of the surgery will be administered in the form of a puff on the surface of each tonsil.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Mahin Seidhejazie
Street address
Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2256
Fax
+98 41 3526 2256
Email
seidhejazie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
sina_raeisi7007@yahoo.com
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farhad Khayat Zahiri
Position
Fellowship of Pediatric Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2256
Email
farhad_zahiri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seidhejazie
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
seidhejazie@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seidhejazie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
seidhejazie@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