Comparison of the analgesic effect of nebulized ketamine versus intravenous morphine in controlling acute pain in patients coming to the emergency department; A randomized controlled clinical trial.
Comparison of analgesic effect of nebulized ketamine versus intravenous morphine in patients coming to the ER with acute pain.
Design
Randomized, controlled, double blinded clinical trial, phase 3 designed for 84 patients.
Randomization performs with block randomiation.
Settings and conduct
This study will be performed on patients coming to the Emergency room of Golestan hospital of Ahvaz, complaining of acute pain.
The ER doctor will order nebulized Ketamine and infusion of normal saline serum in the case group and intravenous Morphine and nebulized sterile water in the control group.
The researcher and the patient don't have any information about the treatment.
After the patient got the analgesic drug, the researcher will ask about the level of the pain in decided minutes.
Participants/Inclusion and exclusion criteria
The condition to enter the study consists of the patients coming to the ER with acute pain greater than 7 out of 10 estimated by visual analogue scale.
The conditions not to enter the study are; having mental illness mentioned by the patient; head trauma; ischemic heart disease; acute heart failure; respiratory distress; systolic blood pressure higher than 180 mmHg or less than 90 mmHg; asthma; high intracranial pressure; pregnancy; addiction; inability to describe pain; severe pain and need to use more than one dose of the drugs or need to change the drug; using analgesic drug before admission or history of allergy to ketamine or morphine.
Intervention groups
Patients with acute pain coming to the emergency department.
Main outcome variables
Pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220418054586N1
Registration date:2022-12-04, 1401/09/13
Registration timing:retrospective
Last update:2022-12-04, 1401/09/13
Update count:0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Sahar Gholamzaheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 843 2046
Email address
sahar.ghz97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-12, 1401/07/20
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of nebulized ketamine versus intravenous morphine in controlling acute pain in patients coming to the emergency department; A randomized controlled clinical trial.
Public title
Comparison of analgesic effect of nebulized Ketamine versus intravenous Morphine in acute pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute pain in patients referred to the ER with a Visual analog scale (VAS) equivalent to or greater than 7 out of 10
Exclusion criteria:
Having a mental illness mentioned by the patient
Head trauma
Ischemic heart disease
Acute heart failure
Respiratory distress
Systolic blood pressure greater than 180 mmHg or less than 90 mmHg
Asthma
High intracranial pressure
Pregnancy
Addiction
Inability to describe the pain
Using other analgesics before admission
History of being allergic to Ketamine or Morphine or any contraindication of using these drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the decided drug orders will be written on separate sheets to a certain number and then they will be placed in sealed envelopes and randomly numbered. Then the pockets will be offered to the emergency department doctor so that he can order the analgesic drug based on the order of each pocket.
The researcher has to record the patient's name in a separate table along with the number of the pocket and after concluding the data collection, this table will be checked and compared to the numbers and names written on each pocket.
Blinding (investigator's opinion)
Double blinded
Blinding description
Behind the researcher confirms the inclusion criteria and randomly chooses the sample, the patient will be presented to the emergency department doctor to enter the study.The researcher offers the doctor a pocket that has the method of study, and the doctor has to order the analgesic drugs according to the instruction and then covertly write down and record the patient's name in the pocket of related intervention. The doctor also can not give any information about the the drug to the researcher and the patient.
In the case group, 1.5 mg per kg of Ketamine will be diluted in 5 ccs of sterile water and nebulized in 5 minutes, and also 100 ccs of Normal saline serum will infuse intravenously for 15 minutes, and in the in control group 0.1 mg per kg Morphine sulfate will be infused intravenously in 100 ccs of Normal saline and also 5 ccs of sterile water will be nebulized; in order to make the trial double-blinded.
After prescribing the analgesic drug, the researcher records the patient's name and Visual Analogue Scale in decided minutes on another sheet and table.
After concluding the data collection, the recorded data from the pockets and the researcher's table will be conformed to perform the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jondishapour Ahvaz university of medical sciences.
Street address
Golestan Hospital, Mofid Ave., Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Approval date
2022-04-18, 1401/01/29
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.016
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain level
Timepoint
Before intervention and in 5, 10, 20, 40, 60 minutes after intervetion.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Side effects
Timepoint
60 minutes after receiving an intervention.
Method of measurement
A questionnaire that includes possible side effects after receiving the drugs.
Intervention groups
1
Description
Intervention group: Patients coming to the ER with pain level greater than 7 out of 10 who get treated by 1.5 mg per kg nebulized ketamine.
Category
Treatment - Drugs
2
Description
Control group: Patients coming to the ER with pain level greater than 7 out of 10 who get treated by 0.1 mg per kg intravenous morphine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Hasan Motamed
Street address
Golestan Hospital, Mofid Ave., Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 3816
Fax
+98 61 3320 4516
Email
golestanhospital@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zakerkish
Street address
Golestan Hospital, Mofid Ave., Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3812
Fax
+98 61 3311 3812
Email
motamed-h@ajums.ac.ir
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
Sahar Gholamzadeh
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Hospital, Mofid Ave., Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
sahar.ghz97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hasan Motamed
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Hospital, Mofid Ave., Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3374 3001
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
Sahar Gholamzadeh
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Hospital, Mofid Ave., Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
sahar.ghz97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available