In this study, intravenous pain relief and side effects of three drugs, acetaminophen, diclofenac suppository and intramuscular injection of tramadol are determined and compared.
Study on 105 pregnant women over 34 weeks for elective cesarean section at Al Zahra Hospital, Tabriz Vtalqany have been done and are willing to participate in the study.The patients are taking pain medications before surgery or have a history of mental problems and anxiety are excluded. Patients were randomly divided into three equal groups of 35 persons .
After entering the patient's medical department is aware of the three groups of patients, the drug.
For the first group, rectal suppositories diclofenac 100 mg every 8 hours (made in Iran, drug manufacturing company) For the second group IV Acetaminophen 1g/100ml infusions every 6 hours 15 minutes (making Iran Couble drugs) And for third group , Tramadol 50mg intramuscular injection every 8 hours (made in Iran, drug manufacturing companies). Pain will be measured every 2, 6 and 24 hours after surgery whith Visual assay of pain (VAS) by scaled ruler (0 to 10). This is a double blind study. Pain is considered as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301235448N3
Registration date:2013-04-10, 1392/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-10, 1392/01/21
Registrant information
Name
Fateme Mallah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133336360
Email address
mallahf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research,Tabriz University of Medical Mciences
Expected recruitment start date
2013-01-29, 1391/11/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the analgesic effects of intravenous acetaminophen , intramuscular tramadol and suppository diclofenac in the treatment of cesarean pain
Public title
Comparision the analgesic effects of intravenous acetaminophen , intramuscular tramadol and suppository diclofenac in the treatment of cesarean pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 - Pregnant women who are candidates for elective or emergency cesarean section to link to the list of operating room training center - Al Zahra Hospital, Tabriz and taleghany hospital have been. 2 - pregnant women over 34 weeks 3 - patient willingness to participate in the study exclusion criteria of study: 1 - Patients who have any reason to take any pain medications before surgery. 2 - Have the contra indications for NSAID or paracetamol or tramadol prescription, such as peptic ulcer, coagulopathy, renal failure, liver failure, asthma, and allergy medicines .... 3 - a history of mental problems and anxiety
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university institutional ethics review board
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
5/4/9921
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
Pain Relief
Timepoint
Pain of 2 hours, 6 hours and 24 hours after surgery is measured
Method of measurement
Visual assay of pain (VAS) by scaled ruler (0 to 10) is zero, no pain and 10 the worst pain at the show, be assesse
Secondary outcomes
1
Description
Improve mobility
Timepoint
Up to 8 hours after surgery
Method of measurement
Questionnaire
2
Description
reduce the risk of postoperative thromboembolic disease
Timepoint
After Surgery
Method of measurement
Questionnaire
3
Description
Improve the ability of the mother to child care and breastfeeding
Timepoint
After Surgery
Method of measurement
Questionnaire
4
Description
Shorten the period of hospitalization
Timepoint
After Surgery
Method of measurement
Questionnaire
5
Description
Reduce hospital costs And increase patient satisfaction
Timepoint
After Surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Group1 versus rectal diclofenac 100 mg every 8 hours (made in Iran, drug manufacturing company)
Category
Treatment - Drugs
2
Description
In group2: IV Acetaminophen 1g/100ml infusion for 15 minutes every 6 hours in patients over 50 kg. In patients under 50 kg, 15 mg / kg every 6 hours (making Iran Couble medicine)
Category
Treatment - Drugs
3
Description
In group3: muscle tramadol 50mg injections every 8 hours (made in Iran, drug manufacturing company) will be used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital,Taleghani Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Mciences
Full name of responsible person
vice chancellor of research
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Mciences
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
Tabriz University of Medical Sciences
Full name of responsible person
D.Fatemeh Mallah
Position
associte proffesor
Other areas of specialty/work
Street address
Alzahra Hospital, bagh-shomal, Arteshe Jonoubi street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
wrhrcenter@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Mallah
Position
gynecologist
Other areas of specialty/work
Street address
Alzahra Hospital, bagh-shomal, Arteshe Jonoubi street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
wrhrcenter@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Fatemeh Mallah
Position
Assistent professor
Other areas of specialty/work
Street address
Taleghani Hospital Rah Ahan Sq
City
Tabriz
Postal code
Phone
+98 41 1556 6449
Fax
Email
mallahf@tbzmed.ac.ir; wrhrcenter@gmail.com;
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)