Comparison of the effectiveness of intranasal Midazolam, oral Melatonin and distraction method in reducing stress and pain caused by intravenous cannulation in children 3 to 10 years old
Evaluation of the effectiveness of inhaled midazolam and oral melatonin with the effectiveness of a non-pharmacological method in reducing pain and stress caused by intravenous line implantation in children referred to the emergency department of Imam Hossein Children's Hospital
Design
The clinical trial has a control group and with parallel groups, it is blinded and randomized. 120 children from 3 to 10 years old who have inclusion criteria are randomly divided into 4 categories of controls and interventions using a random allocation software.
Settings and conduct
After randomization, we assign children to one of the 4 study groups in emergency room. In the control group, the usual routine of emergency, and in the intervention groups, drugs or distraction method is presented. The nurse responsible for venipuncture and the researcher determining the score and stress are blinded.
Participants/Inclusion and exclusion criteria
Children aged 3 to 10 years who need venipuncture and whose parents have informed consent to their child's participation in the study. Whenever the age of the child allows, he/she will be informed about the study. Exclusion criteria: hearing or vision impairment; acute or chronic hypnotic and analgesic use; history of sleep apnea; drug allergies; risk of aspiration; airway disorders.
Intervention groups
Children aged 3 to 10 years should go to the emergency room who are candidates for intravenous line insertion. These children fall into 4 groups. The control group has a venipuncture as a routine. The Melatonin group receives the appropriate dose of Melatonin orally 30 minutes before venipuncture. The Midazolam group receives the appropriate dose through the nose 15 minutes before venipuncture. The distraction card group focuses on the cards from 3 minutes before the venipuncture to the entire process.
Main outcome variables
Procedural pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220128053852N2
Registration date:2023-03-04, 1401/12/13
Registration timing:retrospective
Last update:2023-03-04, 1401/12/13
Update count:0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
Minoo Saeidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3386 6266
Email address
minoo.saeidi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intranasal Midazolam, oral Melatonin and distraction method in reducing stress and pain caused by intravenous cannulation in children 3 to 10 years old
Public title
Procedural pain and anxiety in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parental consent
No urgent need for venipuncture
3 to 10 years old childs
Exclusion criteria:
Hearing and vision disorders that prevent the child from interacting
Dissatisfaction of parents to continue the study at any time during the intervention
Chronic or acute use of a sedative drug
The child has been taking painkillers, even acetaminophen, for the last 6 hours
Symptoms of a child's airway disorder
Patients with American Society of Anesthesiologists ’(ASA) classification from grade 3 upwards
Urgent need for venipuncture including decreased level of consciousness, shocks, severe respiratory distress, uncontrolled seizures, arrhythmia
Children at high risk for aspiration such as gastroesophageal reflux disease or gastrointestinal motility disorders
Age
From 3 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
we will use blocked randomsation. Using the Random Allocation software 2, for 4 study groups, 15 blocks of 8 were calculated for a sample size of 120 people, each person will be identified with a unique code (consisting of two letters and a Latin number). To assign the child to each of the 4 study groups, an envelope containing a unique code and treatment group will be delivered to the child's parents. The project associate nurse, who is stationed next to the nurse responsible for venipuncture, will open the envelope and specify the type of intervention before starting the venipuncture.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the nurse who performs the venipuncture also applies the analgesic method to the child. The nurse who records clinical signs before and after venipuncture is unaware of the type of analgesia applied. The same nurse also gives the child the scale of pain that the child is supposed to grade. The film that is to be taken from the child's facial expressions will be taken by the pediatric resident, but the pain and anxiety will be scored by the presenter and the project partner separately and based on the film. However, both of them are not aware of the type of painless intervention in the patient who will be graded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan, Imam Khomeini Ave, Imam hossein children university hospital
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Approval date
2021-12-19, 1400/09/28
Ethics committee reference number
IR.MUI.MED.REC.1400.696
Health conditions studied
1
Description of health condition studied
Procedural pain and anxiety in children
ICD-10 code
Y84.9
ICD-10 code description
Medical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Pain caused by intravenous line insertion
Timepoint
Determining pain score during and after venipuncture
Method of measurement
Face, Legs, Activity, Cry, Consolability scale and Visual analogue scale
Secondary outcomes
1
Description
child anxiety
Timepoint
Child's stress before and during intravenous line insertion
Method of measurement
Children's Emotional Manifestation Scale
Intervention groups
1
Description
Control group: 3 to 10 year olds need venipuncture for which no intervention is applied
Category
Prevention
2
Description
Intervention group 1:Melatonin drug under the brand name Nem Life is given to the child at a dose of half a milligram per kilogram of the child's body weight and a maximum of 5 mg orally, 30 minutes before venipunctur
Category
Treatment - Drugs
3
Description
Intervention group 2: Midazolam ampoule with a dose of two tenths of a milligram per kilogram of body weight and a total volume of half a cc is used intranasally 15 minutes before inserting the intravenous line and once for the child. After administering the medicine in the nose, the nostril is kept closed for 30 seconds. Midazolam ampoule is produced by Kimidaro factory and is 5 mg.
Category
Treatment - Drugs
4
Description
Intervention group 3: Use of in-house distraction cards modeled after similar cards from Buzzy UK which are shown to the child 3 minutes before the venipuncture, and the co-nurse asks the child the questions on the back of the picture card that are related to the pictures and their details to distract her.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Children Hospital
Full name of responsible person
Minoo Saeidi
Street address
Isfahan, Imam Khomeini Ave, Imam Hossein Children Hospital
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir
Web page address
http://www.ehuch.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Street address
Isfahan, Hezar Jarib Ave, Isfahan University of Medicine
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Web page address
http://www.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Ave, Imam Hossein Children Hospital
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
minoo.saeidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
minoo.saeidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3886 6266
Email
minoo.saeidi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data except videos taken from a potential child can be shared after unidentified individuals.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For academic use by faculty members of universities in the country and around the world
From where data/document is obtainable
Email to Dr. Minoo Saeidi at minoo.saeidi@gmail.com
What processes are involved for a request to access data/document