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The effect of implementing pain control instructions on sedation and duration of mechanical ventilation in patients admitted to the intensive care unit of Hakim Jorjani Hospital in 2020

Protocol summary

Study aim
Determining the effect of implementing pain control instructions on sedation and duration of mechanical ventilation in patients admitted to the intensive care unit of Hakim Jorjani Hospital in 2020
Design
Clinical trial with control group,With parallel,Non-blind,Randomized,Groups on 40patients
Settings and conduct
In the intensive care unit of Hakim Jorjani Hospital in Gorgan.Patients who are on Constant positive pressure or Spontaneous mode are evaluated according to pain control guidelines.The patient's sedation is interrupted,Fentanyl(1micrograms per kilogram per hour) infused as needed.After 4 hours,the patient is evaluated according to a Burn checklist.When a score above17 is obtained,The separation is performed as follows:Injection of a dose of intravenous dexamethasone,Application of one hour of oxygen 6to7 liters per minute on the T-piece,If tolerated if the endotracheal tube,after oxygenated,The tube is removed and if Having a truck,the administration of oxygen is interrupted by a T-piece.The patient is constantly monitored to connect to the ventilator if needed and to be among the unsuccessful cases;If tolerated,It will be one of the successful cases.
Participants/Inclusion and exclusion criteria
Inclusion criteria:having a endotracheal tube or tracheostomy, need for a ventilator,score higher than3 Richmond scale,score 5to13 of the Glasgow scale.Exclusion Criteria:Having kidney disease,Allergy to Morphine and Fentanyl
Intervention groups
Intervention group:Pain control instructions, pain behavioral scale and Richmond relaxation scale are performed and if sedation is needed according to these tools.according to the Bern checklist,separation from the ventilator is done according to the protocol.Control group:No additional drugs or placebo are administered
Main outcome variables
Pain control;Sedation;Duration of mechanical ventilation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210906052394N1
Registration date: 2021-10-18, 1400/07/26
Registration timing: registered_while_recruiting

Last update: 2021-10-18, 1400/07/26
Update count: 0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Maryam Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4332 3916
Email address
maryam.zareia1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing pain control instructions on sedation and duration of mechanical ventilation in patients admitted to the intensive care unit of Hakim Jorjani Hospital in 2020
Public title
Implementation of pain control instructions on sedation and duration of mechanical ventilation in patients admitted to the intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a endotracheal tube or tracheostomy tube Need for mechanical ventilation Inability to communicate verbally Insensitivity to Morphine and Fentanyl No kidney disease Having a systolic blood pressure greater than 100 mm Hg A score above 3 on the Richmond scale A score between 5 Up to 13 on the Glasgow scale
Exclusion criteria:
Allergy to Morphine and Fentanyl Having kidney disease Score below 3 on the Richmond Scale Having a systolic blood pressure of less than 100 mm Hg
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Chalous Branch
Street address
Shahid Amini alley ,60 metri Ave,Emam Ali Blvd
City
Marvdasht
Province
Fars
Postal code
7371753519
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.IAU.CHALUS.REC.1399.019

Health conditions studied

1

Description of health condition studied
Pain Control
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Sedation
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Mechanical Ventilation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain control
Timepoint
Consecutively every 4 hours after starting the study
Method of measurement
Behavioral tools for measuring pain(BPS)

2

Description
Sedation
Timepoint
Consecutively every 4 hours after starting the study
Method of measurement
Richmond agitation sedation acale

3

Description
Duration of mechanical ventilation
Timepoint
Consecutively every 4 hours after starting the study
Method of measurement
BURNS' WEAN ASSESSMENT PROGRAM (BWAP)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patient is evaluated every 4 hours according to the Pain Control Instruction. If the patient needs pain relief (pain assessment with Pain Behavioral Scale), morphine 1 to 5 mg is used intravenously and Repeat every 10 minutes if needed. Maximum to 10 milligram per kilogram per hour is used. If the patient is not relieved with this amount of drug, it is evaluated using the Richmond sedation criterion and if necessary, 1 to 4 milligram of midazolam is injected intravenously. Repeat every 15 minutes if needed. Maximum to 10 milligram per houre can be used. At the threshold of separation from the mechanical ventilation device, the patient's sedation is discontinued and if necessary, fentanyl is infused at a dose of 1 micrograms per kilogram per hour. 4 hours after separation from the mechanical ventilator, using the Bern checklist, if a patient scores above 17, we use a single dose of intravenous dexamethasone (0.1 milligram per kilogram).
Category
Behavior

2

Description
Control group: "The control group continues to receive sedations as directed by the physician and does not receive any additional medications or placebos.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hakim Jorjani Hospital, Gorgan
Full name of responsible person
Maryam Zarei
Street address
Shahid Amini alley, 60 Metri Ave,Emam Ali Blvd
City
Marvdasht
Province
Fars
Postal code
7371753519
Phone
+98 71 4332 2047
Email
Maryam.zareia1369@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Scientific Association of Islamic Azad University, Aliabad Katoul Branch
Full name of responsible person
Maryam Zarei
Street address
Shahid Amini alley, 60 Metri Ave,Emam Ali Blvd
City
Marvdasht
Province
Fars
Postal code
7371753519
Phone
+98 71 4332 2047
Email
Maryam.zareia1369@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Aliabad Katoul Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Maryam Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Amini alley,60 Metri Ave,Emam Ali Blve
City
Marvdasht
Province
Fars
Postal code
7371753519
Phone
+98 71 4332 2047
Email
Maryam.zareia1369@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Amini alley,60 Metri Ave,Emam Ali Blvd
City
Marvdasht
Province
Fars
Postal code
7371753519
Phone
+98 71 4332 2047
Email
Maryam.zareia1369@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Amini alley,60 Metri Ave,Emam Ali Blvd
City
Marvdasht
Province
Fars
Postal code
7371753519
Phone
+98 71 4332 2047
Email
Maryam.zareia1369@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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