Evaluation the effects of melatonin versus placebo on amount of opioids intake in patients admitted to intensive care unit.
Design
Randomised, controlled, parallel group trial with blinded outcome assessment. Randomisation was centralised with simple randomization with random number tables
Settings and conduct
Fifty two patients in age group 18 to 80 years admitted to intensive care unit of Ahvaz Golestan hospital are randomly divided by random number tables into control and intervention groups (n=26 cases). Patients, researchers responsible for data collection and analyses are blind to the groups allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria are age range 18 – 65 year and traumatic patients who are admitted to intensive care unit; The exclusion criteria are patients with GCS less than 4, pregnant patients, patients with renal and liver failure, patients with brain tumor and allergic reaction to melatonin.
Intervention groups
In the Intervention group, on arrival at the intensive care unit, the patients will be received melatonin with dose of 3 mg every night until discharge. In the control group, on arrival at the intensive care unit, the patients will be received placebo every night until discharge.
Main outcome variables
The amount of prescribed opioid analgesic medication during hospitalization, duration of hospitalization, the time required for mechanical ventilation and rate of mortality will compared between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190912044752N1
Registration date:2019-10-28, 1398/08/06
Registration timing:registered_while_recruiting
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Farahmand Kalantari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 4303
Email address
kalantari.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effects of Melatonin versus Placebo on Amount of Opioids Intake in Patients Admitted to Intensive Care Unit
Public title
Evaluation the Effects of Melatonin on Amount of Opioids Intake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 – 80 year
Traumatic patients who are admitted to intensive care unit
Exclusion criteria:
Patients with GCS less than 4
Pregnant patients
Patients with renal and liver failure
Patients with brain tumor
Allergic reaction to melatonin
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group and the odd numbers for the control group are considered. According to the number of patients, they are randomly assigned to one of the intervention or placebo groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, responsible for collecting data and data analyzer are blind to the groups allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.AJUMS.REC.1396.949
Health conditions studied
1
Description of health condition studied
Traumatic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of prescribed opioid analgesic medication
Timepoint
Daily from admission and starting intervention to discharge
Method of measurement
Total receiving dose of opioid analgesic medication
2
Description
Duration of hospitalization
Timepoint
Duration of admission to discharge
Method of measurement
Checklist
3
Description
The time required for mechanical ventilation
Timepoint
Duration of hospitalization
Method of measurement
Checklist
4
Description
Rate of mortality
Timepoint
Duration of hospitalization
Method of measurement
The number of patients who died
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On arrival at the intensive care unit, the patients will be received melatonin with dose of 3 mg every night until discharge.
Category
Treatment - Drugs
2
Description
Control group: On arrival at the intensive care unit, the patients will be received placebo every night until discharge.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farhad Soltani
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3037
Email
soltani-f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Farahmand Kalantari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3037
Email
farahmandbm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farhad Soltani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3037
Email
soltani-f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farahmand Kalantari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3037
Email
farahmandbm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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