The effect of applying pain control algorithm on physiologic indexes and weaning in patients hospitalized in intensive care units
Design
In this research, 396 eligible patients being under mechanical ventilation in intensive care units of Ahvaz Golestan and Emam Khomaini hospitals will be chosen. Patients will be allocated to two equal groups of intervention and control groups using blocking randomization method.
Settings and conduct
This intervention study without blinding and two groups of intervention and control will be conducted on intensive care units of Ahvaz Golestan and Emam Ghomaini hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having level of consciences between 3-5 based on Glasgow Coma Scale; having airway or tracheostomy tubes; being under mechanical ventilation using synchronized intermittent mandatory ventilation mode without intake of muscle relaxants; ability to move at least one of limbs; having stable hemodynamic.
Exclusion criteria: having severe face injuries; inability for verbal communication; being under mechanical ventilation more than 48 hours; having smoking and cigarettes addiction; suffering from cancers; sensitivity to Morphine and Fentanyl drugs; intake of muscle relaxants using intermittent infusion; having renal and liver diseases.
Intervention groups
In intervention group, firstly morphine will be injected with dosage of 0.1 milligram per weight using bolus method. Then, 30 minutes after injection, pain and physiological indices will be assessed and recorded. If the pain will be more than 5, a single dosage of Morphine will be injected again using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded again. Pain and physiological indices will be assessed and recorded each 60 minutes until obtaining of pain score less than 5, and after that each 4 hours until complete weaning of patient from ventilator. In control group, drug will be administer based on hospital routine, and one hour after intervention pain and physiological indices will be assessed and recorded again. Further assessment will be done based on nursing diagnosis. If the pain will be less than 5, then daily assessment for weaning will be implemented in both groups.
Main outcome variables
Pain, physiologic indexes and weaning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170829035984N1
Registration date:2018-01-03, 1396/10/13
Registration timing:registered_while_recruiting
Last update:2018-01-03, 1396/10/13
Update count:0
Registration date
2018-01-03, 1396/10/13
Registrant information
Name
Zahra Karimi
Name of organization / entity
Ahvaz Gundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
karimi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of applying and non-applying of pain control algorithm on physiologic indexes and weaning in patients hospitalized in intensive care units
Public title
The effect of applying pain control algorithm on physiologic indexes and weaning
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having level of consciences between 3-5 based on Glasgow Coma Scale
Having airway or tracheostomy tubes
Being under mechanical ventilation using synchronized intermittent mandatory ventilation mode without intake of muscle relaxants
Ability to move at least one of limbs
Having stable hemodynamic
Exclusion criteria:
Having severe face injuries
Inability for verbal communication
Being under mechanical ventilation more than 48 hours
Having smoking and cigarettes addiction
Suffering from cancers
Sensitivity to Morphine and Fentanyl drugs
Intake of muscle relaxants using intermittent infusion
Having renal and liver diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
396
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to groups using blocking randomization method.
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.AJUMS.REC.1396.350
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
2
Description of health condition studied
Weaning from ventilator status
ICD-10 code
Z99.11
ICD-10 code description
Dependence on respirator [ventilator] status
3
Description of health condition studied
Physiological indices
ICD-10 code
R09.89
ICD-10 code description
Other specified symptoms and signs involving the circulatory and respiratory systems
Primary outcomes
1
Description
Pain
Timepoint
Before and after drug intervention
Method of measurement
Behavioral pain scale
2
Description
Physiological indices
Timepoint
Before and after drug intervention
Method of measurement
Researcher made checklist
3
Description
Weaning form ventilator
Timepoint
Daily
Method of measurement
Researcher made checklist
Secondary outcomes
1
Description
------
Timepoint
------
Method of measurement
------
Intervention groups
1
Description
Intervention group: Pain and physiological indices (heart rate, diastolic and systolic blood pressures, respiratory rate, and level of arterial oxygen saturation) of patients will be assessed and recorded in three shift works each 4 hours. If the pain will be more than 5, then nurse should alleviate pain with pain control algorithm. Firstly Morphine with dosage of 0.1 milligram per weight will be injected using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded. If the pain will be more than 5, a single dosage of Morphine will be injected again using bolus, and 30 minutes after injection pain and physiological indices will be assessed and recorded again. Pain and physiological indices will be assessed and recorded each 60 minutes until obtaining of pain score less than 5, and after that each 4 hours until complete weaning of patient from ventilator. If the pain will be less than 5, then daily assessment for weaning will be implemented.
Category
Treatment - Drugs
2
Description
Control group: Pain and physiological indices (heart rate, diastolic and systolic blood pressures, respiratory rate, and level of arterial oxygen saturation) of patients will be assessed and recorded in three shift works each 4 hours. If the pain will be more than 5, then nurse should alleviate pain without pain control algorithm based on hospital routine. One hour after intervention pain and physiological indices will be assessed and recorded again. Further assessment will be done based on nursing diagnosis. If the pain will be less than 5, then daily assessment for weaning will be implemented.