To assess effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer’s solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determiniation of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120411665N1
Registration date:2013-01-26, 1391/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-26, 1391/11/07
Registrant information
Name
Morteza Delkhosh Reihany
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1669 2724
Email address
mdelkhosh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2011-12-26, 1390/10/05
Expected recruitment end date
2012-12-25, 1391/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Melatonin on postoperative pain and blood loss after cesarean section
Public title
Evaluation of melatonin's effect on pain and blood loss after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women at term (37—40 wks); cesarean section;spainal anesthesia; with out current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.
Excluding criteria: Anemia (Hb8 g%); multiple gestation; antepartum hemorrhage; poly-hydramnios; two or more previous cesarean sections; a history of previous rupture uterus.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Australian New Zealand Clinical Trials Registry
Secondary trial Id
ACTRN12612000117819
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar ave.
City
Qazvin
Postal code
3419759811
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
d/20/3893
Health conditions studied
1
Description of health condition studied
postoperative hemorrhage
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Primary outcomes
1
Description
amount of blood loss after cesarean delivery
Timepoint
determination of Hemoglobin values both before surgery and 12 h following surgery
Method of measurement
determination of Hemoglobin values
2
Description
Time to first requirement of analgesic supplement
Timepoint
Time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
Method of measurement
Verbal Pain Scale[ VRS]>4
Secondary outcomes
1
Description
hemodynamic variables
Timepoint
hemodynamic variables 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 ,25,30 min after the injection
Method of measurement
measurement by nonivasive automatic blood pressure
2
Description
severity of anxiety
Timepoint
5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 ,25,30 min after the injection
Method of measurement
(VAS)Visual Anxiety Scale
Intervention groups
1
Description
Patient received sublingual melatonin 3mg , single dose, 15-20 min before spinal anesthesia .
Category
Treatment - Drugs
2
Description
Patient received sublingual melatonin 6mg, single dose, 15-20min before spinal anesthesia.
Category
Treatment - Drugs
3
Description
Patient received sublingual placebo , single dose , 15-20min before spinal anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Morteza Delkhosh Reihany
Street address
Talegany ave.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shafi Khany
Street address
Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Beigom Khezri
Position
Asociated Professor
Other areas of specialty/work
Street address
Kosar Hospital, Talegany ave.
City
Qazvin
Postal code
3415613176
Phone
+98 28 1223 6374
Fax
+98 28 1223 6378
Email
mkhezri@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Beigom Khezri
Position
Asociated Professor
Other areas of specialty/work
Street address
Kosar Hospital, Talegany ave.
City
Qazvin
Postal code
3415613176
Phone
+98 28 1223 6374
Fax
+98 28 1223 6378
Email
mkhezri@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Morteza Delkhosh Reihany
Position
Professional Assistant
Other areas of specialty/work
Street address
Kosar Hospital, Talegany ave.
City
Qazvin
Postal code
3415613176
Phone
+98 28 1223 6374
Fax
+98 28 1223 6378
Email
mdelkhosh@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)