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Comparison the effect of topical ketamine,morphine and lidocaine spray on post operative pain in tonsillectomy

Protocol summary

Summary
The purpose of this study is to investigate the effecacy of local ketamine, Morphin, and Lidocaine spray for controlling pain after tonsillectomy in children; in this clinical trial, 124 children with the age of 3-12 who selected for tonsillectomy will be divided to four group ; Ketamine group (k), Morphin group (M), Lidocain group (L), and Control group (C). The premedication, induction and maintenance of anesthesia in all of patient will be similar. At the end of surgery 0.5 mg/kg ketamine's spray in group (k), 0.05 mg/kg morphin's spray in group (M), 2 mg/kg lidocaine's spray in group (L), and normal saline spray in group C (8 puffs) will be used on the surface of surgery zone. After ex tubation and the entrance of patient to recovery room, pain scaling will be assessed for 1 hour (with 20 minute intervals) by personnel who were not aware of research methods. Pain control will be scaled with FLACC Pain Scaling System. In this system if anyone of patient in recovery room complained for severe pain, score 6 and more, will received pethidine 0.5 mg/kg for relief.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104236256N1
Registration date: 2011-06-18, 1390/03/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Sevak Hatamian
Name of organization / entity
Qazvin university of medical sciences and health servics
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6381
Email address
sehatamian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellorfor research, Qazvin University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-08-29, 1389/06/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of topical ketamine,morphine and lidocaine spray on post operative pain in tonsillectomy
Public title
Comparison the effect of topical ketamine,morphine and lidocaine spray on post operative pain in tonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Elective tonsillectomy surgery; age between 3-12 years; did not use anti convulsive, antiinflamatory or analgesic agents; negative history of hypersensitive reactions to morphine or lidocaine or hyperactive airway disease such asthma and testimonial form patients Exclusion : using anti convulsive, antiinflamatory or analgesic agents; history of hypersensitive reactions to morphine or lidocaine or hyperactive airway disease such asthma
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences Ethics committee
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
4350/20/28

Health conditions studied

1

Description of health condition studied
Hypertrophy of tonsils
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils

Primary outcomes

1

Description
Pain
Timepoint
During 20 Min
Method of measurement
FLACC (the face, legs, activity, cry and consolability)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention:lidocain spray 10%(100mg/ml) with dose 2mg/kg
Category
Prevention

2

Description
Control : normal saline spray
Category
Prevention

3

Description
Intervention:ketamine spray 1%(10mg/ml)with dose 0.5mg/kg
Category
Prevention

4

Description
Intervention:morphin spray 0.1%(1mg/ml)with dose 0.05% mg/kg
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shid Rajee Hospital
Full name of responsible person
Dr Sevak Hatamian
Street address
Padeghan Street
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Shahid bahonar Blvd
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Sevak Hatamian
Position
Resident Anesthasia
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1222 2452
Fax
Email
sehatamian@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Hosseini Jahromi
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
papaya812002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Sevak Hatamian
Position
Anaesthesia Resident
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
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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