Comparison of intravenous injection of acetaminophen (apotel) and pethidine on the severity of postoperative pain in patients with cesarean section under spinal anesthesia
Objectives: Comparison of intravenous injection of acetaminophen (apotel) and pethidine on the severity of postoperative pain in patients with cesarean section under spinal anesthesia in Sayyad Shirazi Hospital. Study design: Population of study: 80 women aged 17 to 40 years old. Groups of study: The first group received intravenous acetaminophen (1000 mg), group 2: pethidine (1mg / kg), simple randomized, double blind. Inclusion criteria: Elective surgery- no allergic reaction. exclusion criteria: Dissatisfied to participate in the study -having liver or renal disease. B- Interventions: Determine Severity of pain at hours 0, 2, 4, 6, hours after anesthesia and administration of drugs in two groups. The severity of pain with using criteria standard (VAS). C-time of intervention: In recovery after surgery. D- Main outcomes: Determine the severity of pain in the two drug groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407099697N4
Registration date:2017-09-04, 1396/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Fozieh Bakhsha
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 8011
Email address
bakhsha@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous injection of acetaminophen (apotel) and pethidine on the severity of postoperative pain in patients with cesarean section under spinal anesthesia
Public title
Comparison of intravenous injection of acetaminophen (apotel) and pethidine on the severity of postoperative pain in patients with cesarean section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 1 and 2 ASA class of Anesthesia; Term gestational age; absence of chronic diseases such as cardiovascular; hepatic and renal disease.
exclusion criteria: hypersensitivity to any drug such as acetaminophen; local anesthetics and opioid; having liver or renal disease; diabetes, and patients who used analgesic drugs (opioids, NSAID and corticosteroid) within 8 to 12 hours before the intervention.
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Golestan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology,Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd, Gorgan
City
Gorgan
Postal code
49341-74515
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
9309052108412
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Severity of pain
Timepoint
at Hour 0, 2, 4, 6
Method of measurement
Visual Scale of Pain
Secondary outcomes
empty
Intervention groups
1
Description
intravenous acetaminophen 1000mg، based on average pain severity at Hour 0, 2, 4, 6
after local anesthetic in the recovery unit, Daroupakhsh Pharmaceutical product
Category
Treatment - Drugs
2
Description
Pethidine 1 mg per kg body weight, based on average pain severity at Hour 0, 2, 4, 6 after local anesthetic in the recovery unit, Daroupakhsh Pharmaceutical product
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital of Gorgan
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Golestan University
Full name of responsible person
Mohammad Hossein Tazikeh, Director of Vice Chancellor Research and Technology
Street address
Vice Chancellor for Research and Technology,Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd, Gorgan, Golestan
City
Gorgan
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 and Technology of Golestan University
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
Golestan University of Medical Sciences
Full name of responsible person
Fozieh Bakhsha
Position
MSc of Nurse anesthesiology,Instructor of school of paramedical sciences
Other areas of specialty/work
Street address
Department of Nurse Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences,at the beginning of Shast Kola,Hirkan Blvd, Gorgan, Golestan province, Iran