Protocol summary

Summary
The purpose of this double-blind randomized clinical trial study, is to determine and compare the effect of local injection of bupivacaine and lidocain and epinephrine composition on post tonsillectomy pain. Case study samples, are 4-10 year- old children candidate for tonsillectomy, admitted in ENT ward in Imam Sajjad hospital. Samples with Inclusion criteria, will be chosen non-random and then will be placed in three groups by random blocks allocation and this continue until the samples are complete. Sample size is 29 patients in each group (a total of 87 people). Gathering Information will be done by direct observation, demographic check list and Wong-Baker pain scale. After Ethics committee of Yasuj University of Medical Sciences approval and parents informed consent, all patients will be under similar general anesthesia method. The method of cold knife dissection will be similar in all patients. 5 minutes before the surgical incision, in the first group, 2 ml of bupivacaine 0.125, in the second group 2 ml of 1% lidocaine combined and epinephrine 1: 200,000, will be injected locally in the bed and around the tonsils and tonsillectomy will be done. There is no intervention in Group 3. After surgery and transferring the patients to the ENT ward, pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker pain scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072529065N1
Registration date: 2017-06-08, 1396/03/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Mahin Roozitalab
Name of organization / entity
Yasuj University of Medica Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5142
Email address
mohammadi.b1391@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Yasuj University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of local injection of bupivacaine with lidocain and epinephrine composition on post tonsillectomy pain
Public title
The effect of bupivacaine with lidocain and epinephrine composition on the pain in patients undergoing tonsillectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient candidate for elective tonsillectomy; children aged 4 to 10 years; consent of the parents; lack of co-morbidities; negative history of surgery; The ability to verbal communication; cognitive and Mental health. Exclusion criteria: metabolic and endocrine diseases; coagulation disorders; mental retardation; positive history of allergy to drugs; pre-tonsilar abscess; hypertension; psychotic disorder; chronic pain; want to withdraw the study; creates complications in patients like bleeding, Late recovery (2 hours post operation); receiving narcotic drug during study; obesity
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomize Allocation

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences
City
Yasuj
Postal code
Approval date
2016-01-02, 1394/10/12
Ethics committee reference number
ir.yums.rec.1394.121

Health conditions studied

1

Description of health condition studied
Tonsilectomy
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids

Primary outcomes

1

Description
pain
Timepoint
2,4,6 post operation surgery
Method of measurement
wong- baker scale

Secondary outcomes

1

Description
Vital Signs
Timepoint
2,4,6 Post Operation Surgery
Method of measurement
Sphygmomanometer,Thermometer

Intervention groups

1

Description
Intervention group: After induction of anesthesia, cold knife tonsillectomy will be performed. 5 minutes before the surgical incision, in the first group 2 mL of 0.125 bupivacaine, in the second group 2 mL of 1% lidocaine and 1:200,000 epinephrine composition, will be injected locally on the bed and around the tonsils with a single technique as a fan of the upper and lower poles of the tonsils and tonsillectomy will be done. The duration of anesthesia and surgery asses, also patients' vital signs will be recorded before induction of anesthesia, during surgery and in the recovery room. After surgery and transferring the patients of recovery room to the ENT ward, patients' Vital Signs and demographic data collected by check list and pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker Pain Scale.
Category
Treatment - Drugs

2

Description
Control group: After induction of anesthesia, cold knife tonsillectomy will be performed. There is no intervention in Group 3. The duration of anesthesia and surgery asses, also patients' Vital Signs will be recorded before induction of anesthesia, during surgery and in the recovery room. After surgery and transferring the patients of recovery room to the ENT ward, patients' Vital Signs and demographic data collected by check list and pain will be measured 2 hours, 4 hours and 6 hours after surgery with Wong-Baker Pain Scale.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sajad(A) Hospital
Full name of responsible person
Mahin Roozitalab
Street address
Paramedicin Faculty, Yasuj University of Medical Sciences,
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Hossien Marry Oryad
Street address
Vice chancellor for research of Yasuj University of Medical Sciences, University of Medical Sciences, Yasuj
City
Yasuj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Yasuj University of Medical Sciences
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
Yasuj University of Medical Sciences, Yasuj, Iran
Full name of responsible person
Mahin Roozitalab
Position
MSC in Medical Surgical Nursing/ Faculty Member
Other areas of specialty/work
Street address
College Paramedicine, Yasuj University of Medical Sciences, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5142
Fax
Email
mohammadi.b1391@yahoo.com؛ roozitalab95@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences, Yasuj, IRAN
Full name of responsible person
Mahin Roozitalab
Position
MSC in Medical Surgical Nursing
Other areas of specialty/work
Street address
paramedicin College, Yasuj University of Medical Sciences, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5142
Fax
Email
mohammadi.b1391@yahoo.com؛ roozitalab95@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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