Comparing the preemptive analgesia effects of oral magnesium oxide and naproxen for hysterectomy surgery in Afzalipour Hospital , Kerman ,Year 1398
Design
A concealed, triple blinded, randomized (random sequence numbers) clinical trial with two arm parallel group (32 patients in each group)
Settings and conduct
This study was conducted among patients candidate hysterectomy in Afzalipour hospital, Kerman. patients received magnesium oxide and naproxen before operation and non of participants, main investigator and data analyser did know the patients allocation (triple blinded)
Participants/Inclusion and exclusion criteria
Inclusion criteria: no history of sensitivity to magnesium and naproxen; lack of liver diseases; no lactation
Exclusion criteria: drug or opiod addiction; concomitant treatment with analgesic or anti-inflammatory drugs
Intervention groups
Patients in intervention group received a magnesium oxide tablet (500 mg) and patients in control group received naproxen tablet (500 mg) before operation.
Main outcome variables
Pain score; Pulse rate changes; Blood pressure changes; Time between end of operation and first prescription of analgesic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190819044559N1
Registration date:2019-11-04, 1398/08/13
Registration timing:retrospective
Last update:2019-11-04, 1398/08/13
Update count:0
Registration date
2019-11-04, 1398/08/13
Registrant information
Name
Morteza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
mortezahashemian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-13, 1398/05/22
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-08-13, 1398/05/22
Actual recruitment end date
2019-10-14, 1398/07/22
Trial completion date
2019-10-14, 1398/07/22
Scientific title
Comparing the preoperative analgesia effects of oral Magnesium oxide and Naproxen for hysterectomy surgery in Afzalipour hospital , Kerman, 2019
Public title
Effect of oral Magnesium oxide on preoperative analgesia in hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No history of sensitivity to magnesium and naproxen
Lack of liver diseases
No kidney or cardiovascular dysfunction
no lactation
age between 35 to 65
Exclusion criteria:
drug or opiod addiction
neurological disorder, pain or abuse of opiod analgesic
Concomitant treatment with analgesics or anti-inflammatory drugs
Chronic treatment with magnesium or calcium channel blockers
Patients with complicated appendectomy
Age
From 35 years old to 65 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients randomly divided in two groups (32 patients in each group) using random allocation sequence with SAS statistical software. according to this method a simple randomization list product and patients`involvement in each group determine base on order entry. we used sequentially numbered, sealed opaque envelopes for allocation concealment. patients (individuals) were the randomization units.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, main investigator and data analyser were masked of patients allocation. patients did not know which drug prescribed and checklists did not contain any drug name. only the nurse know the name of medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Vice-challenger of Research, Ebn-e sina St., Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.KMU.AH.REC.1398.081
Health conditions studied
1
Description of health condition studied
Pain after hysterectomy surgery
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain score after hysterectomy surgery
Timepoint
After surgery and consciousness of the patient
Method of measurement
VAS scale
2
Description
Pulse rate changes
Timepoint
During operation
Method of measurement
Arm cuff
3
Description
Blood pressure changes
Timepoint
During operation
Method of measurement
Arm cuff
4
Description
Time between end of operation and first prescription of analgesics
Timepoint
The first time that patient need analgesic
Method of measurement
patient demand
Secondary outcomes
1
Description
Chill feeling
Timepoint
After operation
Method of measurement
Clinical symptoms
2
Description
Nausea
Timepoint
After operation
Method of measurement
Clinical symptoms
3
Description
Vomiting
Timepoint
After operation
Method of measurement
Clinical symptoms
Intervention groups
1
Description
Intervention group: receiving oral Magnesium oxide (500 mg) 1.5 hour before surgery
Category
Prevention
2
Description
Control group: receiving oral Naproxen (500 mg)1.5 hour before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Morteza Hashemian
Street address
Afzalipour hospital, Imam khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Mortezahashemian@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Vice-challenger of Research, Ebn-e sina St., Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vice-challenger of Treatment, Jomhori Eslami blvd.
City
Kerman
Province
Kerman
Postal code
7618747653
Phone
+98 34 3211 3012
Email
Mortezahashemian@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vice-challenger of Treatment, Jomhori Eslami blvd.
City
Kerman
Province
Kerman
Postal code
7618747653
Phone
+98 34 3211 3012
Fax
Email
mortezahashemian@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vice-challenger of Treatment, Jomhori Eslami blvd.
City
Kerman
Province
Kerman
Postal code
7618747653
Phone
+98 34 3211 3012
Fax
Email
mortezahashemian@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available