Effect of preoperative oral Melatonin on pain intensity after Cesarean section
Design
This study is a double-blind randomized, controlled clinical trial (Phase 3). 204 patients are assigned to three groups by blocking method. The randomization process will be done with Random Allocation Software.
Settings and conduct
The aim of this study was to determine the effect of preoperative Melatonin on postoperative pain intensity in patients undergoing elective cesarean section referred to Imam Khomeini hospital in Sari. Patients are divided into three groups: group A will receive a 5 mg Melatonin tablet, group B will receive a 10 mg Melatonin tablet, and group C will receive a placebo one hour before surgery. Patients and researchers are unaware of group placement. In the operating room, all patients have the same spinal anesthesia under the same anesthesia protocol. Pain intensity, nausea, vomiting, itching and headache in the study groups are evaluated and recorded 2, 6, 12 and 24 hours after surgery. In addition, the patient's first request for postoperative analgesia, the patient's opioid intake within 24 hours of surgery, and the time of the first bed rest are assessed and recorded by the anesthesiologist. It is noteworthy that the placebo required for the study was made of starch and the same color and shape of Melatonin in Sari School of Pharmacy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who completed the informed consent form, Lack of sensitivity to Melatonin.
Exclusion criteria: Prolongation cesarean section (more than 1.5 hours), third cesarean section (CS III) and higher.
Intervention groups
Group A: One 5 mg melatonin tablet (made by Nature Made, USA)
Group B: One 10 mg melatonin tablet (made by Nature Made, USA)
Group C: Placebo one hour before surgery
Main outcome variables
Pain intensity and amount of drugs using
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170220032676N3
Registration date:2020-11-18, 1399/08/28
Registration timing:prospective
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Farshad Hassanzadeh Kiabi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4000
Email address
fhasanzadehk@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-04, 1399/09/14
Expected recruitment end date
2021-12-05, 1400/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative oral Melatonin on pain intensity after cesarean section
Public title
Effect of preoperative oral elatonin on pain intensity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who completed the informed consent form
Candidate for non-emergency cesarean section
Lack of sensitivity to Melatonin
Second cesarean section
No history of seizures, diabetes, preeclampsia, eclampsia, hypertension and organ transplantation
who do not use drugs to 24 hours before the intervention
No alcohol or drug abuse
Term pregnancy age
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process is done with Random Allocation Soft ware.The block size is six and the number of blocks is 34. The randomization is done using block method. Unit of randomization is individual. Randomization is done using a table of random numbers and to generate random sequences as online, computer is used. For concealing treatment allocation, the list of treatments are placed in the enclosed and numbered (to maintain order of sequences) envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers will be unaware of group placement, and drugs will be coded at the School of Pharmacy at the time of manufacture.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Mazandaran University of Medical Sciences
Street address
Valiasr bolvard, Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.061
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
P03.4
ICD-10 code description
Newborn (suspected to be) affected by Cesarean delivery
Primary outcomes
1
Description
Pain intensity
Timepoint
2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale (VAS)
2
Description
The amount of drugs using
Timepoint
2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale (VAS)
2
Description
Itching
Timepoint
2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale (VAS)
3
Description
Headache
Timepoint
2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale (VAS)
Intervention groups
1
Description
Intervention group: Group A received 5 mg Melatonin tablets (Made by Nature Made, USA)
Category
Treatment - Drugs
2
Description
Intervention group: Group B received 10 mg Melatonin tablets (Made by Nature Made, USA)
Category
Treatment - Drugs
3
Description
Control group: Melatonin orally, 1 hour before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Negar Shazdeh Ahmadi
Street address
Imam Khomeini Hospital, Razi street, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
asanzadehk@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Valiasr bolvard, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
fhasanzadehk@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Negar Shazdeh Ahmadi
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Razi street, Sari
City
Sari
Province
Mazandaran
Postal code
Phone
+98 11 3304 4000
Email
asanzadehk@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Farshad Hasanzadeh Kiabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr bolvard, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
fhasanzadehk@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Negar Shazdeh Ahmadi
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Valiasr bolvard, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
asanzadehk@mazums.ac.ir
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