Investigating the effect of sublingual melatonin on the amount of narcotics used in laparotomy patients hospitalized in the ward
Design
This is a clinical trial study with parallel groups, double-blinded randomized, will be conducted on 30 patients undergoing laparotomy admitted to the ICU . Assignment of patients to the study groups will be done by generation of random-numbers table and using computer and excel software.
Settings and conduct
This controlled study is performed on laparotomy patients hospitalized in the ICU. At least 60 patients are randomly assigned to one of the two intervention groups. Patients and researchers will not know about the type of treatment and patient grouping, and thus, this study will remain double-blind until the end of the work.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age older than 18 years, patients who need hospitalization in the intensive care unit for more than 48 hours due to laparotomy surgery; Exclusion from the study: presence of liver failure (liver enzyme more than three times the normal limit), kidney failure (GFR<60), history of brain tumor, history of sensitivity to melatonin.
Intervention groups
Patients in the first group (intervention) will receive 5 mg of sublingual melatonin tablets every night upon entering the intensive care unit, and patients in the second group (control) will receive a placebo drug with the same shape and appearance as melatonin at 9:00 p.m. . The administration of medicine or placebo continues for 7 days in patients in the intensive care unit.
Main outcome variables
The amount of need to receive opioids, the amount of need to receive antibiotics, changes in pain level, possible side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220807055631N1
Registration date:2022-08-30, 1401/06/08
Registration timing:prospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Negin Ayoubzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3001 3374
Email address
neginayoubzadeh@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sublingual melatonin on the use of opioids used in patients undergoing laparotomy admitted to the ICU
Public title
Effect of melatonin on opioids used in patients undergoing laparotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years
Patients undergoing laparotomy surgery
requiring hospitalization in the intensive care unit for more than 48 hours
Exclusion criteria:
Presence of liver failure (liver enzyme more than three times the normal limit)
Renal failure (GFR<60)
History of brain tumor
History of sensitivity to melatonin
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(30)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group and the second 30 people will place in the second group. A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomization. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, doctors, nurses, those responsible for data collection and those who evaluate the results will be blinded. The appearance of the placebo is similar to the melatonin pill, and the preparation of the drugs is done by the nurse away from the eyes of the patients. Also, intervention (receiving melatonin or placebo) and evaluation of patients is done by a doctor who does not know about the patient's grouping. The statistical analyzer of the results will not know about the patient grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan Hospital of Jondi Shapoor of Ahwaz University of Medical Sciences
Street address
Golestan Ave., farvardin St.
City
Ahwaz
Province
Khouzestan
Postal code
6133333333
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.043
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K37
ICD-10 code description
Unspecified appendicitis
Primary outcomes
1
Description
The need to receive opioids
Timepoint
daily during ICU stay
Method of measurement
The need for narcotics (and drug dosage) based on the severity of the patient's pain and the doctor's diagnosis
2
Description
The need to receive antibiotics
Timepoint
daily during ICU stay
Method of measurement
Prescribing antibiotics based on doctor's diagnosis
3
Description
Changes in the amount of pain
Timepoint
daily during ICU stay
Method of measurement
based on visual analog scale (VAS)
4
Description
Possible side effects
Timepoint
During ICU stay
Method of measurement
Based on the patient's examination and symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: Patients will receive 5 mg of sublingual melatonin tablets (the company...) at 9:00 p.m. every night upon entering the intensive care unit. Medication prescription for 7 days in patients in the intensive care unit. continues.
Category
Prevention
2
Description
Control group: Patients will receive a placebo pill with the same shape and appearance as melatonin at 9:00 PM every night upon entering the intensive care unit. Placebo administration continues for 7 days in patients in the intensive care unit.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Negin Ayoubzadeh
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
neginayoubzadeh@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnoosh Zakerkish
Street address
Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6133333333
Phone
+98 61 3373 8383
Email
Zakerkish-m@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
Negin Ayoubzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Fax
Email
neginayoubzadeh@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Ayoubzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Fax
Email
neginayoubzadeh@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Ayoubzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Fax
Email
neginayoubzadeh@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publishing as an article
When the data will become available and for how long
always
To whom data/document is available
All researchers
Under which criteria data/document could be used
To be presented in scientific texts under conditions of confidentiality and copyright
From where data/document is obtainable
Dr Negin Ayoubzadeh
What processes are involved for a request to access data/document