1. Home
  2. Approved trials
  3. » فارسی

Comparison of oral Promethazine's effect with Midazolam and with Placebo on preoperative anxiety in children (3-8 years old)

Protocol summary

Summary
(1) Aim: Determination and comparison of oral Promethazine's effect, oral Midazolam and Placebo on preoperative anxiety, pulse rate, blood pressure, respiratory rate, nausea and vomiting in referred children (3-8 years old) to Khorramabad Shohadaye Ashayer Hospital. (2) Design: Randomized / Double blind / Controlled with Placebo / Single center. (3) Setting and conduct: Sampling method is based on inclusion criteria. Children are categorized into one of the three groups (Promethazine, Midazolam and Placebo) based on simple randomized allocation. Then interventions are done on them and results are recorded in questionnaire. (4) Participants, Inclusion and exclusion criteria: Sample volume is 123. Inclusion criteria: Children with 3-8 years old / With American Society of Anaesthesiologists (ASA) grade 1 and 2 / under general anaesthesia / elective surgery / lack of chronic disease, prematurity, growth retardation, brain disorders, vision and acoustic disorders / with a written consent form from parents. Exclusion criteria: History of allergy to used drugs in this study / Children with emergency surgery. (5) Interventions: Interventions include three groups (Promethazine, Midazolam and Placebo) and are done 2 hours before surgery. (6) Primary outcome measure: Preoperative anxiety by Yale Preoperative Anxiety Scoring (YPAS)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012073010447N1
Registration date: 2012-09-24, 1391/07/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-24, 1391/07/03
Registrant information
Name
Marzie Sokuti
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1320 6359
Email address
nadri.s@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2012-07-17, 1391/04/27
Expected recruitment end date
2012-09-17, 1391/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral Promethazine's effect with Midazolam and with Placebo on preoperative anxiety in children (3-8 years old)
Public title
Effect of Promethazine and Midazolam on preoperative anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Children with 3-8 years old / With American Society of Anaesthesiologists (ASA) grade 1 and 2 / under general anaesthesia / elective surgery / lack of chronic disease, prematurity, growth retardation, brain disorders, vision and acoustic disorders / with a written consent form from parents. Exclusion criteria: History of allergy to used drugs in this study / Children with emergency surgery
Age
From 3 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is double blind because: (1) Patient does not know that receives which one of three drugs. (2) A nurse of preoperative holding area gives drug to child not researcher. Researcher does not know that patient had received which one of three drugs.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khoramabad-Brujerd road
City
Khoramabad
Postal code
Approval date
2012-07-14, 1391/04/24
Ethics committee reference number
70670/200

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F40, F41,
ICD-10 code description
Neurotic, stress-related and somatoform disorders

Primary outcomes

1

Description
Preoperative anxiety
Timepoint
Before intervention, One hours and 30 minutes after intervention ( Separation's time of child from parent) , Two hours after intervention (Before induction of anaesthesia)
Method of measurement
According to Yale Preoperative Anxiety Scoring (YPAS) by questionnaire

Secondary outcomes

1

Description
Age
Timepoint
Before intervention
Method of measurement
According to number of year by questionnaire

2

Description
Sex
Timepoint
Before intervention
Method of measurement
According to phenotype by questionnaire

3

Description
Blood pressure (BP)
Timepoint
Before intervention, Two hours after intervention
Method of measurement
According to millimeter of Mercury by barometer

4

Description
Pulse rate (PR)
Timepoint
Before intervention, Two hours after intervention
Method of measurement
According to number of heartbeat in minute by physical exam

5

Description
Respiratory rate (RR)
Timepoint
Before intervention, Two hours after intervention
Method of measurement
According to number of breathing in minute by physical exam

6

Description
Nausea and vomiting
Timepoint
Before intervention, After surgery
Method of measurement
According to yes or no by questionnaire

Intervention groups

1

Description
Midazolam group: Midazolam syrup (Producted by Midazolam ampule and juice) / Two milligram (mg) in 1 milliliter (ml) / Midazolam Chloridric Acid / With single dose of 0.5 mg per kilogram (kg) up to a maximum of 20 mg / Oral / Once and two hours before surgery / Abureihan Company / Brand name: Versed
Category
Treatment - Drugs

2

Description
Promethazine group: Promethazine syrup / Promethazine Chloridric Acid / With single dose of 0.5 mg per kg up to a maximum of 20 mg / Five mg in 5 ml / Oral / Once and two hours before surgery / Tehran Shimi Company / Brand name: Phenergan
Category
Treatment - Drugs

3

Description
Control group: Oral / Injection water / With single dose of 2-5 ml / Once and 2 hours before surgery / Dana Company / Brand name: Injection water
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorramabad Shohadaye Ashayer Hospital
Full name of responsible person
Doctor (Dr) Sedighe Nadri, Anaesthesiologist, Academic
Street address
Shohadaye Ashayer Hospital, Enghelab Street
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Mohammad Hasan Kayedi
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad - Brujerd road
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences, Vice chancellor for research
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
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedighe Nadri
Position
Anaesthesiologist, Academic
Other areas of specialty/work
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad- Brujerd road
City
Khorramabad
Postal code
Phone
+98 6616200155169
Fax
Email
nadri.s@lums.ac.ir
Web page address
www.lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedighe Nadri
Position
Anaesthesiologist, Academic
Other areas of specialty/work
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad-Brujerd road
City
Khorramabad
Postal code
Phone
+98 6616200155169
Fax
Email
nadri.s@lums.ac.ir
Web page address
www.lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Sedighe Nadri
Position
Anaesthesiologist, Academic
Other areas of specialty/work
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad - Brujerd road
City
Khorramabad
Postal code
Phone
+98 6616200155169
Fax
Email
nadri.s@lums.ac.ir
Web page address
www.lums.ac.ir

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
Loading...