Protocol summary

Summary
aim of the study:show the effect of topical injection of tramadol, ketamine and lidocaine on post-tonsillectomy pain , nausea and vomiting the study is a double blind clinical trial carried out on 60 elective tonsillectomy patients in Imam Khomeini Hospital, Ahwaz, in 2014.inclusin criteria is patient with chronic tonsillitis and exclusion criteria is patients with any underlying disease, with drug reaction history, and whom the surgery time is more than one hour. The patients randomly divide into four groups ; tramadol, lidocaiene ketamin, placebo post operation pain and nausea and vomiting record by an ENT resident whom does not know about groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121520320N1
Registration date: 2015-04-10, 1394/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-10, 1394/01/21
Registrant information
Name
Somayeh Araghi
Name of organization / entity
ENT Department of the Jondishapour Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 9664
Email address
araghi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapor University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical injection of tramadol, ketamine and lidocaine on post-tonsillectomy pain, nausea and vomiting
Public title
The effect of topical injection of tramadol, ketamine and lidocaine on post-tonsillectomy pain, nausea and vomiting
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: patient with chronic tonsillitis exclusion criteria: patients with any underlying disease, with drug reaction history, and whom the surgery time is more than one hour
Age
From 4 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of Jondishapour Ahvaz University of Medical Sciences
Street address
Jondishapour Ahvaz University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Approval date
2015-01-03, 1393/10/13
Ethics committee reference number
Ajums.rec.1393.346

Health conditions studied

1

Description of health condition studied
chronic tonsillitis، tonsils and adenoids hypertrophy
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids

Primary outcomes

1

Description
pain
Timepoint
1,4,8,16,24 hour post-operation
Method of measurement
faces pain scale

2

Description
nausea
Timepoint
1,4,8,16,24 hour post-operation
Method of measurement
4 option scale: none,mild, moderate, sever

3

Description
vomiting
Timepoint
1,4,8,16,24 hour post-operation
Method of measurement
none,mild(1 episode),moderate(2-3), severe(>3 episode)

Secondary outcomes

1

Description
surgery time
Timepoint
start and finish time of surgery
Method of measurement
minutes

Intervention groups

1

Description
Intervention group 1: Ketamin 0.5 mg/kg 2cc total, 1cc injection before operation in each tonsillar bed
Category
Treatment - Drugs

2

Description
Intervention group 2: tramadol 2 mg/kg Daroupakhsh, Iran 2cc total, 1cc injection before operation in each tonsillar bed
Category
Treatment - Drugs

3

Description
Intervention group 3: lidicaine hydrochloride 20 mg/ml +epinephrine 0.00125% 2cc total, 1cc injection before operation in each tonsillar bed
Category
Treatment - Drugs

4

Description
Control goup: saline 2 cc, 1cc in each tonsilar bed
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Somayeh Araghi
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Ahvaz Jondishapour University of Medical Sciencess
Full name of responsible person
Nader Saki
Street address
ENT Department, Imam Khomeini Hospital , 24 Metri Avenue, Ahavz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Ahvaz Jondishapour University of Medical Sciencess
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
Jondishapour Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Somaye Araghi
Position
Resident
Other areas of specialty/work
Street address
ENT Department, Imam Khomeini Hospital, 24 Metri Street
City
Ahvaz
Postal code
Phone
+98 61 3333 9664
Fax
Email
savesina@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
ENT Departmen,Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Somayeh Araghi
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT Department, Imam Khomeini Hospiatl
City
Ahvaz
Postal code
Phone
+98 61 3333 9664
Fax
Email
savesina@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Somayeh Araghi
Position
Resident
Other areas of specialty/work
Street address
ENT Department, 24 Metri Avenue, Imam Khomeini Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3333 9664
Fax
Email
savesina@yahoo.com
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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