Determining the efficacy of fentanyl on pain resulting from endotracheal suction in mechanically ventilated patient in the PICU
Design
Two arm parallel group, randomized, double blinded, phase 2 on 50 patients. Randomization with odd or even number of the bed of admission.
Settings and conduct
The study was performed in pediatric intensive care units in the Emam Hosein children hospital in 2020, Isfahan, Iran. Demographic data of all patients including age, gender, reason of admission and mechanical ventilation duration were collected. We measured pain with FLACC scale and physiologic indices (heart rate and systolic and diastolic arterial pressure, respiratory rate, and oxygenation saturation) by the time of endotracheal suctioning. Patients were randomly divided into 2 groups receiving 1 μg/kg fentanyl or normal saline as placebo. The drugs were administered before endotracheal suctioning and the pain score and physiologic indices changes were evaluated. Participants, main researcher, doctors and nurses were blinded in this study. The data gathering and analyses were not blinded. Drugs were numbered by the pediatric resident in 2 cc syringes with the same volume and dilution percentage. The nurse who was not aware of the type of injectable product.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged two months to 12 years under mechanical ventilation; signing the written informed by the parents to participate.
Exclusion criteria: history of any neuromuscular disorders; diagnosis of acute respiratory distress syndrome (ARDS); treatments with muscle relaxants; treatment with another analgesic drug an hour before the intervention.
Intervention groups
in control group injection of 1μg/kg fentanyl diluted up to 2 cc and in placebo group injection of 2 cc normal saline
Main outcome variables
Pain was measured with behavioral scale and vital sign variability.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210408050902N1
Registration date:2021-11-22, 1400/09/01
Registration timing:registered_while_recruiting
Last update:2021-11-22, 1400/09/01
Update count:0
Registration date
2021-11-22, 1400/09/01
Registrant information
Name
Sharareh Babaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3275 0621
Email address
sharareh.babaie@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of fentanyl with placebo on pain relief during endotracheal suctioning in ventilated children
Public title
Effect of fentanyl on pain during endotracheal suctioning in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged two months to 12 years under mechanical ventilation
Signing the written informed by the parents to participate in this study
Exclusion criteria:
History of any neuromuscular disorders
Diagnosis of acute respiratory distress syndrome (ARDS)
Treatments with muscle relaxants
Treatment with another analgesic drug an hour before the intervention
Age
From 2 months old to 12 months old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers tool according to new admission on odd numbers or even numbers of the bed
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, main researcher, doctors and nurses were blinded in this study. The data gathering and analyses were not blinded. Drugs were numbered by the pediatric resident in 2 cc syringes with the same volume and dilution percentage and placed in the ward daily. The nurse who was not aware of the type of injectable product.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hezar Jerib Ave., Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.MUI.MED.REC.1399.1106
Health conditions studied
1
Description of health condition studied
Neurologic disorders
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Respiratory diseases
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Infectious diseases
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Metabolic diseases
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Renal diseases
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Hematologic diseases
ICD-10 code
ICD-10 code description
7
Description of health condition studied
GI diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before and after endotracheal suction
Method of measurement
FLACC behavioral scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fentanyl with dose one micro-gram per kilogram diluted up to 2 cc before endotracheal suction slow intravenous injection
Category
Treatment - Drugs
2
Description
Control group: Intervention group: 2 cc Normal Salin before endotracheal suction slow intravenous injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein children hospital
Full name of responsible person
Sharareh Babaie
Street address
Emam Khomeini street
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Azadi square
City
Esfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2234
Email
international@mui.ac.ir
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
Sharareh Babaie
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini street
City
Esfahan
Province
Isfehan
Postal code
8158856311
Phone
+98 31 3275 0621
Email
sharareh.ba@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sharareh Babaie
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hosein hospital, Imam Khomeini avenue
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
sharareh.ba@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sharareh Babaie
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hosein hospital, Imam Khomeini avenue
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
0098 31 333866266
Email
Sharareh.ba@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
share all of the participant personal data
When the data will become available and for how long
access instantly after publication
To whom data/document is available
Researcher works in academic and scientific institutions
Under which criteria data/document could be used
Use the data for similar study with any kind of analysis is allowed
From where data/document is obtainable
authors E-Mail address
What processes are involved for a request to access data/document
Applying with E-Mail then the data will be send within two weeks