One of the major problems is pain after surgery. This study aimed to compare the analgesic effect of diclofenac suppository and Apotel on pain after cesarean section in nulliparous women. This study is single-blind clinical trial. All qualified nulliparous women with singleton pregnant and 38 to 42 weeks gestational age will be selected by convenience sampling.Then, using random blocks will be put in two groups of Apotel and diclofenac suppository. One hour and thirty minutes after spinal anesthesia and before Back pain after surgery in both groups were given 50 mg of pethidine vial. And then to a group of mothers expressed the need for analgesic 100 mg suppositories diclofenac And the other group vial Apote (1000 mg) will be Infusion by the researcher assistant. Pain intensity will be assessed before intervention by the McGill Pain Questionnaire short form and then within 24 hours, 2 times the distance of 6 to 8 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092513336N2
Registration date:2016-04-22, 1395/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Maryam Aradmehr
Name of organization / entity
School of Nursing and Midwifery Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 3363
Email address
pouravazm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Apotel and suppositories diclofenac on pain relief after cesarean section among primiparous women
Public title
Comparison Apotel and suppositories diclofenac on pain relief after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: minimum education subjects as reading and writing, lives with his wife, a singleton pregnancy, gestational age 38 to 42 weeks, primiparous women, healthy baby and the first minute Apgar score 7-10, the same method cesarean delivery and a cross-section (skin and uterus), mothers with vital signs are favorable. Exclusion criteria: The presence of unusual complication of surgery (bladder trauma or other injury during surgery), preoperative fever, Smoking and drug addiction, hysterectomy Associated with cesarean, suffering from medical disorders (diabetes, hypertension, heart disease and vascular, renal, pulmonary, gastrointestinal, thyroid, immune disorders, infectious, psychiatric, metabolic disorders, electrolyte and irritable bowel syndrome), sensitivity to paracetamol, liver and kidney function decline, chronic alcoholism, chronic malnutrition or dehydration, taking probenecid or Sylasyd year or drugs are enzyme induction.
Age
No age limit
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Khorasan Razavi,Mashhad,Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2015-07-30, 1394/05/08
Ethics committee reference number
930562
Health conditions studied
1
Description of health condition studied
Pain after cesarean
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
pain of cesarean section
Timepoint
before the intervention until the 24 hours after intervention
Method of measurement
McGill Pain Questionnaire short
Secondary outcomes
1
Description
Physical activity and psychosocial
Timepoint
12 and 24 hours after cesarean section
Method of measurement
Interview form Pain interference with physical activity and psychosocial
Intervention groups
1
Description
In the intervention group, One hour and thirty minutes after spinal anesthesia and before Back pain after surgery were given 50 mg of pethidine vial. And then expressed the need for analgesic vial Apotel (1000 mg) to 4 times a day will be Infusion by the researcher assistant. and there will be at least a 4-hour interval between two consecutive injections. will be recorded amount Apotel used.
Category
Treatment - Drugs
2
Description
In the intervention group, One hour and thirty minutes after spinal anesthesia and before Back pain after surgery were given 50 mg of pethidine vial. And then expressed the need for analgesic vial Apotel (1000 mg) to 4 times a day will be Infusion by the researcher assistant. and there will be at least a 4-hour interval between two consecutive injections. will be recorded amount Apotel used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad University ofMedical Sciences
Full name of responsible person
maryam aradmehr, Msc of Midwifery School of Nursing and Midwifery Mashhad
Street address
Khorasan Razavi,Mashhad,Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr.tafaghodi
Street address
Khorasan Razavi, Mashhad University Avenue, Building Qureshi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Aradmehr
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Khorasan Razavi, Mashhad, intersection,Doktora Intersection , School of Nursing and Midwifery, Mashhad
City
Mashhad
Postal code
9671883735
Phone
+98 51 5522 1005
Fax
Email
maryam.aradmehr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Azhari sedigheh
Position
Master of Midwifery, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Khorasan Razavi, Mashhad, intersection Doctora, School of Nursing and Midwifery, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
azharis@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Aradmehr
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Khorasan Razavi, Mashhad, intersection,Doktora Intersection , School of Nursing and Midwifery
City
Mashhad
Postal code
9671883735
Phone
+98 51 5522 1005
Fax
Email
maryam.aradmehr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)