Objective: Comparison the therapeutic effects of sublingual buprenorphine and fentanyl intravenous pump for controlling pain after cesarean section with spinal. Design: In this interventional study, 100 women who have criteria for entering the study will be selected and divided into two groups using block randomization method (n=50 in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen. Inclusion criteria: Patients with spinal anesthesia during cesarean section. Exclusion criteria: History of drug abuse. Setting and intervention: In the first group, buprenorphine ( Faran shimi Co.) will be administered sublingually at a dose of 0.4 mg and Will be repeated at 6 and 12 hours after the first dose. At the same time, 100 cc normal saline will be used intravenously for 24 hours. In the second group, the intravenous fentanyl ( Caspian tamin Co.) with a dose of 20 cc per 100 cc of normal saline, will be administered intravenously and continued for up to 24 hours. In this group, sublingual placebo will be used at the start of the intervention and 6, 12 hours after intervention. Outcomes measure: pain score will evaluate according to the VAS score once score at 2, 6, 12, and 24 hours after cesarean section using a structured questionnaire and visual analogue scale. Also The vomiting will be evaluated within 24 hours after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081723559N14
Registration date:2017-08-20, 1396/05/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effects of sublingual buprenorphine and fentanyl intravenous pump for controlling pain after cesarean section with spinal
Public title
Comparison of sublingual buprenorphine and intravenous fentanyl pump for cesarean section pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with spinal anesthesia during cesarean section. Exclusion criteria: History of drug abuse.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medicine Sciences Ethics committee
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
Approval date
2017-04-12, 1396/01/23
Ethics committee reference number
IR.ARUMS.REC.1396.2
Health conditions studied
1
Description of health condition studied
caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
pain
Timepoint
Four times (2,6,12and 24 hours) after intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
vomiting
Timepoint
Up to 24 hours after intervention
Method of measurement
Clinical
Intervention groups
1
Description
In the first group, buprenorphine ( Faran shimi Co.) will be administered sublingually at a dose of 0.4 mg and Will be repeated at 6 and 12 hours after the first dose. At the same time, 100 cc normal saline will be used intravenously for 24 hours.
Category
Treatment - Drugs
2
Description
In the second group, the intravenous fentanyl ( Caspian tamin Co.) with a dose of 20 cc per 100 cc of normal saline, will be administered intravenously and continued for up to 24 hours. In this group, sublingual placebo will be used at the start of the intervention and 6, 12 hours after intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
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, Ardabil University of Medical Sciences