1. Home
  2. Approved trials
  3. » فارسی

A comparison of intravenous magnesium sulfate plus ketamine versus intravenous ketamine alone for acute pain control in long bone fractures

Protocol summary

Study aim
Comparing the anti-inflammatory effect of magnesium + intravenous ketamine versus intravenous ketamine in the control of acute limb fracture pain
Design
A clinical trial with case and control groups, with parallel groups, triple blind, randomized, phase 3 on 180 patients. A table of random numbers is used for randomization.
Settings and conduct
A triple blinded and randomized clinical trial study was conducted in the emergency department of Golestan Hospital. Neither the intervening operator nor the patient nor the person analyzing the results will know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with long bone fractures Conditions of non-entry: unstable hemodynamics, alcohol consumption, neuromuscular diseases, pregnant and lactating women, high blood pressure , history of benzodiazepine and ketamine use, other medical diseases
Intervention groups
The patients were randomly divided into two groups: for the first group, magnesium sulfate at a dose of 20 mg/kg + ketamine at a dose of 0.3 mg/kg, the sample volume was reduced to 20 cc of normal saline, diluted and after registration vas scoring is received as a bolus at minute zero (on arrival) and the patient's pain level is recorded at minutes zero, 5, 15, and 30. For the second group, ketamine alone with a dose of 0.3 mg/kg was diluted to bring the sample volume to 20 cc of normal saline, and after registering the vas scoring at zero minute (on arrival), it was received as a bolus and at minute 0, 5, 15, 30, the pain level of the patient is recorded.
Main outcome variables
Examining the pain reduction effect of magnesium together with ketamine compared to ketamine alone in 0, 5, 15 and 30 minutes; Examining the side effects of using ketamine with the mentioned dose; Examining the side effects of taking ketamine with magnesium at the mentioned dose

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240318061327N1
Registration date: 2024-05-31, 1403/03/11
Registration timing: prospective

Last update: 2024-05-31, 1403/03/11
Update count: 0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Sahar Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 8042
Email address
sahar.rh1377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of intravenous magnesium sulfate plus ketamine versus intravenous ketamine alone for acute pain control in long bone fractures
Public title
Magnesium in pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with long bone fractures aged 18 to 65 years and weighing between 60 to 80 kg and with a vas scoring pain level of more than 4 out of 10 have referred to the Golestan hospital emergency room, and there was no pain relief intervention before that, including the prescription of any medication. have not had
Exclusion criteria:
Unstable hemodynamics, alcohol consumption, neuromuscular diseases, pregnant and lactating women, high blood pressure (systolic more than 145 mmHg and diastolic more than 100 mmHg), history of benzodiazepine and ketamine use, medical diseases (such as heart failure, liver, kidney, stomach ulcer, cardiac arrhythmia).
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Using the table of random numbers: In this method, the members of the community are numbered from 1 to N, then a row and a column of the table are randomly selected. The intersection point of the selected row and column is the starting point of sampling. From this point, a plus or a cross is drawn. All the numbers that are placed on this plus or cross are selected as members of the sample.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients know that they are participating in a study whose purpose is to investigate the analgesic effect of a specific drug, but they do not know the type of injected drug (case or control). The operator who prepares the drug for the patient knows whether the drug is a case or a control using a table of random numbers, and dilutes both drugs to a volume of 20 cc of normal saline, which have the same appearance, and delivers it to the injection operator. Gives . The operator injecting the drug and recording the observations is unaware of the type of injected drug (case or control) and injects both types of drugs in the same way for the patients. At the end of the research, the person analyzing the information is not aware of the case or the control of the data. In this way, the study is triple blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz University of Medical Sciences, Esfand Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1955739761
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.AJUMS.REC.1402.722

Health conditions studied

1

Description of health condition studied
Long bone fracture
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Investigating the analgesic effect of ketamine
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Investigating the analgesic effect of magnesium sulfate + ketamine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Numerical scale of pain intensity
Timepoint
Upon arrival (0) and 5, 15 and 30 minutes
Method of measurement
visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: ketamine alone with a dose of 0.3 mg/kg until the sample volume is 20 cc of normal saline, diluted and received as a bolus after registering the vas scoring at zero minute (on arrival). The amount of pain is recorded at 0, 5, 15, 30 minutes under examination with a visual analog scale.
Category
Treatment - Drugs

2

Description
Intervention group: magnesium sulfate at a dose of 20 mg/kg + ketamine at a dose of 0.3 mg/kg, the sample volume was diluted to 20 cc of normal saline, and after registering the vas scoring at the zero minute (on arrival) to The face of the bolus is received. The amount of pain is recorded at 0, 5, 15, 30 minutes under examination with a visual analog scale.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Hassan Motamed
Street address
Golestan Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1955739761
Phone
+98 61 3374 3009
Email
motamed-h@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hassan Motamed
Street address
Golestan Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1955739761
Phone
+98 61 3374 3009
Email
mtdhsn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hassan Motamed
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1955739761
Phone
+98 61 3374 3009
Email
motamed-h@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hassan Motamed
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1955739761
Phone
+98 61 3374 3009
Email
motamed-h@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hassan Motamed
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1955739761
Phone
+98 61 3374 3009
Email
motamed-h@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be publicly available after publication in authoritative articles
When the data will become available and for how long
After printing the article
To whom data/document is available
All researchers
Under which criteria data/document could be used
All data will be available except for the participants' profile
From where data/document is obtainable
Reputable scientific journals
What processes are involved for a request to access data/document
Search in authoritative articles
Comments
Loading...