not Blind Comparison of analgesic effect of pethedin, diclophenac and morphin after caesarean section in pregnant females came to ValiAsr Hospital of Birjand according to Visual analog Scoring (VAS)
Objectives: comparison of analgesic effect of pethedin, diclophenac and morphin after cesarean section
Design: randomized,not blinded, placebo used, single center, phase 1 trial (not available)
Setting and conduct: according to Include&exclude criteria the population selected and get Informed consent for this study.The Patient wont be informed about type of drug they will get. not blindly all population divided into 3 groups for pain control with different drugs, in each group pain control will be comparised with each other group. Members of Research team member wont be informed about the drug used for patients.
Participants including major eligibility criteria: pregnant females candidates for cesarean section for delivery.
include criteria:
1- Elective cesarean section
2- primy gravid or not complicated cesarean section
3- No Medical condition in Mother
4- using Spinal analgesia for cesarean section
exclusion criteria:
1- history of Medical Condition
2- history of twin pregnancy
3- pethedin hypersensitivity
4- opiom addiction
5- Blood Pressure lower than 90-60 or higher than 180/110
6- history of psychologic disorders
Interventions:
we are going to inervent on pain releaf drugs used after cesarean section, so we use one of drugs (Morphin, Pethedin and Diclofenac) for each one of groups
Main Outcames:
1- pain immediately after cesarean section
2- pain 1 hour after cesarean section
3- pain 12 hour after cesarean section
4- pain 24 hour after cesarean section
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082618934N1
Registration date:2014-11-10, 1393/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-10, 1393/08/19
Registrant information
Name
Seyed hamid Hoseini
Name of organization / entity
Birjand University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 3041
Email address
hamid_hoseini@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
not Blind Comparison of analgesic effect of pethedin, diclophenac and morphin after caesarean section in pregnant females came to ValiAsr Hospital of Birjand according to Visual analog Scoring (VAS)
Public title
Comparison of analgesic effect of pethedin, diclophenac and morphin after caesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective caesarean section; primy gravid or not complicated caesarean section; No Medical condition in Mother (cardiac, respiratory, hepatic or neurologic); using Spinal analgesia for caesarean section;
Exclusion criteria:
history of Medical Condition such as Renal disorders, hypertension during pregnancy, active peptic ulcer, laparostomy, cardiac diseases; history of twin pregnancy; pethedin hypersensitivity; opiom addiction; Blood Pressure lower than 90-60 or higher than 180/110; history of psychologic disorders like Pain Disorders, Sommatization Disorder, and histyric Personality
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In the pethedin and morphin groups, a placebo Suppository will be used as placebo.
In the diclophenac group, a Dextrose Water 5% injection will be used as placebo.
Period and amount of prescription will be similar in all groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Birjand University of Medical science
Street address
Ghafaari ave., Birjand
City
Birjand
Postal code
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
1393-06-04
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Pain immediatly after cesarean section
Timepoint
Iimmediatly after cesarean section
Method of measurement
Visual analog Scoring
2
Description
Pain 1 hour after cesarean section
Timepoint
1 hour after cesarean section
Method of measurement
Visual analog Scoring
3
Description
Pain 12 hour after cesarean section
Timepoint
12 hour after cesarean section
Method of measurement
Visual analog Scoring
4
Description
Pain 24 hour after cesarean section
Timepoint
24 hour after cesarean section
Method of measurement
معیار آنالوگ بینایی
Secondary outcomes
empty
Intervention groups
1
Description
Use Pethedine as analgesic 50 miligram/kilogram Intera muscular three times a day
Category
Treatment - Drugs
2
Description
Use Morphine as analgesic 10 miligram/kilogram Intera rectal three times a day
Category
Treatment - Drugs
3
Description
Use Diclofenac as analgesic 50 miligram/kilogram Intera rectal three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Genycology Department of Valiasr Hospital of Birjand
Full name of responsible person
Ghanbarzadeh N. MD
Street address
Vali Asr Hospital, Ghafari ave., Birjand
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Zarban Dr.
Street address
Birjand University of Medical science, Ghafaari ave., Birjand
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Birjand 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
Birjand University of Medical science
Full name of responsible person
Ghanbarzadeh N. MD
Position
Gynecologyst/ head of Gynecology Department of Birjand University of Medical science
Other areas of specialty/work
Street address
Birjand University of Medical Science, Ghafari Ave., Birjand
City
Birjand
Postal code
Phone
+98 56 1443 3002
Fax
Email
info@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Ghanbarzadeh N. MD
Position
Gynecologist/ Head of Gynecology departmen of Birjand University of Medical Science
Other areas of specialty/work
Street address
Birjand University of Medical Science, Ghafaari Ave., Birjand
City
Birjand
Postal code
Phone
+98 56 1443 3002
Fax
Email
info@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Hosseyni S.H.
Position
Medical Student (Intern)
Other areas of specialty/work
Street address
Birjand University of Mediacal Science, Ghafari Ave., Birjand
City
Birjand
Postal code
Phone
00
Fax
Email
hamid_hoseini@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)