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Comparison of the effectiveness of pharmacological and non-pharmacological methods of reducing pain in retinopathy of prematurity examination

Protocol summary

Study aim
The practical purpose of this study is to reduce the possible side effects of the drugs used for the examination and increase the satisfaction of doctors by using appropriate analgesia methods during the ROP examination in addition to controlling the pain of the baby.
Design
This study, which is a double blind randomized control trial, will be conducted on 300 premature babies born and hospitalized in the NICU of Mehdieh Hospitals . At first, the informed consent form is given to the parents about the need and method of treatment, and after the necessary explanations and acceptance of the condition of the newborns, the candidates for eye examination enter the study.
Settings and conduct
Premature babies born with retinopathy are referred to Mahdieh Hospital within 5 months. This study will be conducted on 300 premature babies who were born and hospitalized in the NICU department. At first, the informed consent form is given to the parents about the need and method of treatment, and after the necessary explanations and acceptance of the condition, newborns candidates for eye examination enter the study.
Participants/Inclusion and exclusion criteria
The inclusion criteria include being hemodynamically stable and alert and able to tolerate oral sucrose 25%, at least one hour has passed since feeding, and the examination will be done before the next meal.Exclusion criteria include the baby of an addict mother, the use of sedative drugs before the examination, connection to a ventilator.
Intervention groups
Investigating the best and most effective pharmacological and non-pharmacological methods in reducing the eye examination pain of premature babies born with ROP referred to Mahdieh Hospital within a period of 5 months.
Main outcome variables
Investigating the best and most effective pharmacological and non-pharmacological methods in reducing eye examination pain in premature babies with ROP.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211225053512N1
Registration date: 2022-12-07, 1401/09/16
Registration timing: prospective

Last update: 2022-12-07, 1401/09/16
Update count: 0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Hamed Razi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
razihamed50@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-19, 1401/09/28
Expected recruitment end date
2023-06-17, 1402/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of pharmacological and non-pharmacological methods of reducing pain in retinopathy of prematurity examination
Public title
Comparison of the effectiveness of pharmacological and non-pharmacological methods of reducing pain in retinopathy of prematurity examination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be hemodynamically stable Be alert And be able to tolerate 25% oral sucrose At least one hour has passed since the feeding The examination will also be done before the next meal
Exclusion criteria:
The baby of an addicted mother Taking sedative before examination Connected to the ventilator
Age
To 37 months old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling based on the table of random numbers (at least 100 babies in each group).Allocation of patients in two groups was done by random block allocation method. The allocation sequence was generated using the free web-based system https://www.sealedenvelope.com/. To produce the sequence, the number of subjects in each block is 6 and 4, and letters A are for the intervention group and letters B are considered for the control group. Finally, 200 samples (24 blocks of 6 and 14 blocks of 4) have been produced in two groups A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, Double Blinde Randomized Control Trial (double blind clinical trial), We decided to put eligible infants in three groups of ketamine and fentanyl and non-pharmacological methods and compare their effectiveness in preventing pain. At least 100 babies in each group are included in the study based on the inclusion criteria and are randomly assigned to three treatment groups. Then, treatment groups are compared based on PIPP (premature infant pain index) which is measured by someone other than a nurse.
Placebo
Not used
Assignment
Parallel
Other design features
According to the definition of the World Health Organization, babies who are born before the 37th week from the first day of the last menstrual period are considered premature.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice President of Research and Technology Shahid Beheshti University of Medical Sciences.
Street address
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Approval date
2022-04-25, 1401/02/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.037

Health conditions studied

1

Description of health condition studied
Pain reduction in the eye examination of premature babies.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Gestational age
Timepoint
After the examination, the vital signs are monitored for 24 hours.
Method of measurement
Premature infant pain profile

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The non-pharmacological group of SADDLING babies - pacifiers and oral sucrose 25% half cc per kilogram of weight.
Category
Treatment - Drugs

2

Description
Intervention group 2: Ketamine 2mg/kg nasally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later.
Category
Treatment - Drugs

3

Description
Intervention group 3: Fentanyl 2 µg/kg nasally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later.
Category
Treatment - Drugs

4

Description
Intervention group 4: Acetaminophen 2 drops/kg orally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Medical Educational and Therapeutic Center Tehran
Full name of responsible person
Hamed razi
Street address
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Shahid Beheshti University of Medical Sciences.
Street address
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamed Razi
Position
Pediatric resident.
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Khoshnoud Shariati
Position
Assistant Professor of Neonatal and Perinatal Medicine.
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Khoshnoud Shariati
Position
Assistant Professor of Neonatal Perinatal Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It will be available only for researchers working in academic and scientific institutions after the official approval of the supervisor and main supervisor, and other personal analyzes are not allowed.
From where data/document is obtainable
Mrs. Dr. Maryam Khoshnood Shariati Mahdieh Hospital Tehran
What processes are involved for a request to access data/document
Visiting in person or calling Dr. Maryam Khoshnoud Shariati at Mahdieh Hospital in Tehran and registering a legal request at the Vice-Chancellor of Education at Mahdieh Hospital.
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