The effect of preoperative sublingual melatonin on postoperative pain severity in patients undergoing colorectal surgery
Design
Double-blind, Randomized, Placebo-controlled, Two Parallel-Group Trial (Intervention group 30 and control group 30)
Settings and conduct
Department of Surgery, Ghaem Hospital, Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion: The patient is a candidate for colorectal surgery; ASA Classification of 1 and 2; Give informed, voluntary and written consent; the patient has not used any narcotic drugs before surgery.
Exclusion: a history of alcohol or drug abuse; a history of Seizure; a history of diabetes
Intervention groups
Intervention group: 6 mg melatonin sublingual one hour before surgery
Control group: 6 mg placebo sublingual one hour before surgery
Main outcome variables
Postoperative pain severity by Verbal rating scale (VRS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190811044506N1
Registration date:2019-08-31, 1398/06/09
Registration timing:prospective
Last update:2019-08-31, 1398/06/09
Update count:0
Registration date
2019-08-31, 1398/06/09
Registrant information
Name
Maryam Shakiba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 5168
Email address
shakibam961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative sub-lingual melatonin on postoperative pain of patients undergoing colorectal surgery
Public title
The effect of melatonin on the severity of postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a candidate for colorectal surgery.
ASA Classification of 1 and 2
Give informed, voluntary and written consent
Have not used any narcotic drugs before surgery.
Exclusion criteria:
a history of alcohol or drug abuse
a history of Seizure
a history of diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria were divided into control and intervention groups using random numbers table by simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects were randomly divided into intervention and control groups after receiving written and informed consent so that they were unaware of their assigned group.
The original drug and placebo, which are similar in shape, color and size, are delivered to the patient by the unconscious clinical caregiver.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakilabad Blvd, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.149
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
T81
ICD-10 code description
Complications of procedures, not elsewhere classified
2
Description of health condition studied
abdominal pain
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain
Primary outcomes
1
Description
Postoperative pain severity
Timepoint
0, 2, 6, 12 and 24 hours after surgery
Method of measurement
Verbal rating scale
Secondary outcomes
1
Description
sedation
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
Ramsay sedation score
Intervention groups
1
Description
Intervention group: 6 mg melatonin sublingual one hour before surgery
Category
Treatment - Drugs
2
Description
Control group: 6 mg placebo sublingual one hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Maryam Shakiba
Street address
Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
shakibam961@mums.ac.ir
Web page address
http://quaem.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Shakiba
Position
َAssisstant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Daneshghah
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3601 5168
Fax
Email
shakibam961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Shakiba
Position
َAssisstant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Daneshghah
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3601 5168
Fax
Email
shakibam961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Shakiba
Position
َAssisstant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Daneshghah
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3601 5168
Fax
Email
shakibam961@mums.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