Protocol summary

Summary
Fentanyl is commonly used as a pre-induction adjunct and can cause fentanyl induced cough. In this study we want to compare the effect of pretreatment lidocaine with fentanyl for suppression of fentanyl induced cough in pediatric patients. This study will perform on 99 Patients of either gender. Inclusion criteria will be ASA I ,II, aged 2 to 10 years old who are scheduled for elective hernioraphy under general anesthesia in Urmia Motahari Hospital, are enrolled in the study. Exclusion criteria include patients with body weight more than 20% of the ideal body weight, emergency hernioraphy, a history of asthma, chronic obstructive lung diseases, chronic cough, upper respiratory tract infection within 4 weeks of Surgery, children with malformation of the tongue and oropharynx, and allergy to the study drugs. All patients will receiving an oral administration of 0.3 mg/kg of midazolam 30 minutes before separation from parents or IV (0.5 mg) and atropine (0.02 mg/kg) when IV access are established before the induction of anesthesia. Patients will randomly allocated using the sealed envelope technique in three groups of 33 each to receive: 1.0 mg/kg lidocaine (I), 0.5 μg/kg fentanyl (II) or placebo equal volume of 0.9% saline (III), 1 min before the IV administration of 2 μg/kg fentanyl over 2second during induction of general anesthesia. A blinded observer, who is not aware of the type of medication given to the patients, will recorded the number of coughing episodes until to 2 minute.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112027677N5
Registration date: 2017-01-02, 1395/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pretreatment Intravenous lidocaine with fentanyl for suppression of fentanyl induced cough in children
Public title
Clinical trial effect of Intravenous lidocaine with fentanyl for suppression of fentanyl induced cough in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Anesthesiologists physical status I ,II; aged 2 to10 years old; elective hernioraphy; general anesthesia Exclusion criteria: patients with body weight less than 20% of the ideal body weight; emergency hernioraphy; a history of asthma; chronic obstructive lung diseases; chronic cough; upper respiratory tract infection within 4 weeks of Surgery; children with malformation of the tongue and oropharynx; allergy to the study drugs
Age
From 2 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The intervening person will inject the drugs to the patient based on the random numbers table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Emergent Street, Resalat avenue, Urmia
City
Urmia
Postal code
5714783734
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ir.umsu.rec.1394.386

Health conditions studied

1

Description of health condition studied
Opioid induced cough
ICD-10 code
A37.9
ICD-10 code description
Whooping cough, unspecified

Primary outcomes

1

Description
cough
Timepoint
Within 2 minutes after fentanyl injection
Method of measurement
patient observation

Secondary outcomes

1

Description
Mean Arterial Blood Pressure
Timepoint
Within 2 minutes after fentanyl injection
Method of measurement
None Invasive Blood Pressure

2

Description
Pulse rate
Timepoint
Within 2 minutes after fentanyl injection
Method of measurement
Electrocardiogram

3

Description
The percentage of arterial oxygen
Timepoint
Within 2 minutes after fentanyl injection
Method of measurement
Pulse Oximetry

Intervention groups

1

Description
Intervention group 1: Fentanyl will be prepared in 5 cc syringes randomly injected.
Category
Treatment - Drugs

2

Description
Intervention group 2: lidocaine will be prepared in 5 cc syringes and after closing cord randomly injected.
Category
Treatment - Drugs

3

Description
Control group: Normal Saline will be prepared in 5 cc syringes randomly injected.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Shahryar Sane
Street address
Kashani Avenue
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Street address
Emergent Street, Resalat avenue, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Street address
Emergent Street, Resalat avenue, Urmia
City
Urmia
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 Urmia University of Medical Sciences
Proportion provided by this source
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
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Assistant Professor
Other areas of specialty/work
Street address
Motahhari Hospital, Department of Anesthesiology
City
Urmia
Postal code
5714615463
Phone
+98 32224777
Fax
+98 44 3346 8967
Email
sane.sh@umsu.ac.ir; shahryarsane@yahoo.com; dr.sh.sane@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergent Street, Resalat avenue
City
Urmia
Postal code
5715781351
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sane.sh@umsu.ac.ir; shahryarsane@yahoo.com; dr.sh.sane@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Assistant professor
Other areas of specialty/work
Street address
Emergent Street, Resalat Avenue
City
Urmia
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sane.sh@umsu.ac.ir; shahryarsane@yahoo.com; dr.sh.sane@gmail.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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