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Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department

Protocol summary

Summary
In a randomized double-blind prospective clinical trial performed in Imam Reza Hospital Emergency Department, 80 infants and children aged 2-10 years with wounds requiring local anesthesia for performing sutures will be included. Prior to the study, parental written informed consents will be obtained. Sampling will be performed confidentially and randomly. Patients will be divided into groups 1 and 2 as follows: Group 1: patients having received oral diphenhydramine for sedation. Group 2: patients having received oral ketamine, midazolam, and atropine for sedation. Medicine acceptance by the child and his/her anxiety will be registered via questioning the parents. If local anesthesia is required, those with anxiety scale of more than 1 will enter the study. Infiltration of the local anesthetic will be registered based on the tranquility degree every 5 minutes. For scores more than 4, or at least 45 minutes later, the tranquilizer will be administered. After the patient sitting on the examination bed, nasal mask will be placed. Consciousness status of the patient will be monitored regularly. All the oral administration of the medicines will be performed under the supervision of an emergency medicine. All behavioral patterns of the child including cry, consciousness, and movement throughout the procedure will be registered and evaluated based on the Houpt scale by a third colleague. In addition to the evaluation of the behaviors of the child, treatment will be performed based on the Houpt scale. After two weeks from the hospital discharge, the probable behavioral changes within two weeks will be registered via telephone connection with the parents. The obtained data will be analyzed using SPSS 16 and to the study the relation between the variables, Chi-square and Mann-Whitney U test will be used. A P value less than 0.05 will be considered statistically significant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212312496N8
Registration date: 2013-01-03, 1391/10/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-01-03, 1391/10/14
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research-Vice chancellor, Tabriz University of Medical Sciences, Iran
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department
Public title
Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 2-10 years having referred to the emergency department for wound stitches requiring local anesthesia prior to the procedure. Exclusion criteria: Patients with the history of psychologic or mental disorders, children with attention deficit-hyperactivity disorder, multiple traumas, GCS<15, common cold, unwillingness of the parents to take part in the study, illiterate parents, known allergy, prior history of erythromycin administration, chronic underlying diseases such as convulsive disorders, patients with lower-extremity ulcers, mucosal ulcers, wounds larger than 4 centimeters or with the depth of more than 0.5 centimeters and single ulcers, too.
Age
From 2 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
9154

Health conditions studied

1

Description of health condition studied
sedation during procedure
ICD-10 code
T88.52
ICD-10 code description
sedation(conscious) (moderate) during procedure

Primary outcomes

1

Description
sedation
Timepoint
Every 5 minutes to 45 minutes after administration of sedatives
Method of measurement
Grade 1: drowsiness, the patient needs a stimulus for waking up- Grade 2: drowsiness, the eyes are closed and patient needs a mild verbal or touch stimulus for waking up- Grade 3: drowsiness, the eyes are open but the eye responsiveness has reduced to low activity- Grade 4: complete awakeness- Grade 5: complete agitation

Secondary outcomes

1

Description
All behavioral patterns of the child including cry, consciousness, and movement throughout the procedure
Timepoint
When local anesthetic injecting and during the procedure
Method of measurement
Based on the Houpt scale

Intervention groups

1

Description
Oral Diphenhydramin : 0.5mg/kg
Category
Prevention

2

Description
Oral ketamin(6mg/kg), Midazolam(0.05mg/kg) and Atropine(0.02mg/kg) cocktail
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr.Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr.seyed kazem shakouri
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hassan Soleimanpour
Position
Anesthesiologist/ Associate professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hassan Soleimanpour
Position
Anesthesiologist/ Associate professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664
Postal code
51664
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hassan Soleimanpour
Position
Anesthesiologist/Associate professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
h_mofid1357@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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