The purpose of the study :The comparison of normal salin pad and 2% lidocaine pad on post-adenotonsillectomy pain
20/5000
Study design: Randomized, double-blind, placebo-controlled, single-center, phase II trial
The study population : Children ages 7 to 15 years undergoing adenotonsillectomy referred to ENT Clinic of Khatamolanbia Hospital in 1394
A: Inclusion criteria:15-7year-old age are undergoing adenotonsillectomy
Exclusion criteria: Known allergy to lidocaine, Analgesic Drug use during the past 24 hours
Number of samples : 104
B : There pad soaked in saline and Lidocaine pads in two different groups
C : 12,6,2 and 24 hours after surgery
D : Increased postoperative analgesia and reduce the need for pain medication after surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122931656N1
Registration date:2017-05-07, 1396/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-07, 1396/02/17
Registrant information
Name
Matin Edizadeh
Name of organization / entity
Zahedan Univerity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 374 1402
Email address
matin.edizadeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
No fee plan
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of normal salin pad and 2% lidocaine pad on post-adenotonsillectomy pain
Public title
The effect of normal saline soaked pads on tonsillectomy pain
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:15-7year-old age are undergoing adenotonsillectomy؛Children with recurrent tonsillitis؛ chronic tonsilitis؛ Obstructive sleep apnea syndrome؛Tonsillar hypertrophy؛ dysphagia
Exclusion criteria: Known allergy to lidocaine؛Renal or hepatic dysfunction؛Analgesic consumption during the last 24 hours؛ Drug abuse (due to its high prevalence in the region)؛ known Favism disease ، Diarrhea؛ dehydrationr ؛ bleeding disorders
Age
From 7 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ZAHEDAN University of Medical Sciences
Street address
Zahedan- dr hesabi square
City
zahedan
Postal code
9816743463
Approval date
2016-01-17, 1394/10/27
Ethics committee reference number
IR.ZAUMS.REC.1394.357
Health conditions studied
1
Description of health condition studied
chronic tonsilitis
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
Pain relief
Timepoint
12,6,2 and 24 hours after surgery.
Method of measurement
asked pain scale
Secondary outcomes
1
Description
Reduce the need for painkillers
Timepoint
6 hours
Method of measurement
pre-arranged questionnaire
Intervention groups
1
Description
Immediately after adenotonsillectomy and extubation pad soaked lidocaine 2% in the intervention group received.All patients remained in hospital for 24 hours after the operation .Postoperative pain using the VAS (visual analog scale) 12,6,2 and 24 hours after surgery were examined.
Category
Treatment - Drugs
2
Description
As before, but with this difference that the control group received normal saline0/9% soaked pad
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Alnbya hospital
Full name of responsible person
Dr Gholam Ali Dashti
Street address
Khatamol Anbia Hospital ، Khatam Square ، Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology, Zahedan University of Medical Science
Full name of responsible person
Dr Refigh Dost
Street address
Zahedan ، Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology, Zahedan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan university of medical science
Full name of responsible person
Matin edizadeh
Position
Medical Intern
Other areas of specialty/work
Street address
Zahedan
City
Zahedan
Postal code
Phone
+98 937 150 5179
Fax
Email
dr.matin_90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan Univervity of Medical Science
Full name of responsible person
Dr Dashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Zahedan
City
Zahedan
Postal code
9816743463
Phone
+98 912 202 3969
Fax
Email
Drdashti50@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan Univercity Of Medical Science
Full name of responsible person
Matin Edizadeh
Position
Medical Student
Other areas of specialty/work
Street address
Dr Hesabi Square
City
Zahedan
Postal code
9816743463
Phone
+98 54 3329 5744
Fax
Email
Dr.Matin_90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)