Comparison of the effects of intravenous Dexamethasone with Acetaminophen in ovarian cyst surgery on pain, nausea and vomiting
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 42 patients.
Settings and conduct
In this randomized double-blind clinical trial performed on 42 women undergoing Ovarian cysts surgery in Mahzad hospital in Urmia, patients in two groups of 21 will randomly receive intravenous Dexamethasone 0.1 mg/kg or intravenous Acetaminophen 15 mg/kg. Patients and statistical analyzers will be unaware of group assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Satisfaction to participate in the study, age between 18 to 65 years.Lack of sensitivity to Dexamethasone and Acetaminophen-Exclusion criteria:Having liver, kidney and heart disease
Comparison of the effects of intravenous Dexamethasone with intravenous Acetaminophen in ovarian cyst surgery on pain, nausea and vomiting
Public title
Effect of intravenous Dexamethasone with intravenous Acetaminophen on pain, nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Age between 18 to 65 years
Lack of sensitivity to Dexamethasone and Acetaminophen
Exclusion criteria:
Having liver, kidney and heart disease
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 10 blocks and one block of 2 subjects (Totally 42 patients). Then, within each block, subjects will be randomly assigned to Dexamethasone and Acetaminophen group . Random assignment will be done using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of their allocation into the intervention groups and the statistical analyzer received the data as codes, not the actual grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-03-02, 1401/12/11
Ethics committee reference number
IR.UMSU.REC.1400.467
Health conditions studied
1
Description of health condition studied
Ovarian cysts
ICD-10 code
N83.20
ICD-10 code description
Unspecified ovarian cysts
Primary outcomes
1
Description
Pain
Timepoint
15 minutes, 0.5, 1, 2, 3, 4, 5 and 6 hours after entering recovery
Method of measurement
Visual Analogue scale
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
It is recorded up to 6 hours after the surgery if observed
Method of measurement
Observation
Intervention groups
1
Description
Intervention group 1: Intravenous Dexamethasone 0.1 mg/kg (Iran Rasht pharmaceutical company) 15 minutes before finishing the surgery
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous Acetaminophen 15 mg/kg (Osveh Company) 15 minutes before finishing the surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahzad Women’s Medical Center
Full name of responsible person
Dr. Hadi Hooshyar
Street address
Mahzad Women’s Medical Center; Hasani street, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 0998
Email
hooshyar.h@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences; Resalat street; Jahad Blvd; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Email
mohebbi.i@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?