Evaluation of the analgesic effect of morphine-ketamine-midazolam combination after surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 66 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
This study is a clinical trial performed at Sina Hospital, Tehran University of Medical Sciences.
Patients are extubated after surgery and recover. In recovery, patients were evaluated based on VAS or Richmond criteria, and if they had a VAS> 4 score or Richmond +2 and above, they entered the study and were randomly assigned to one of the two groups.
The first group received 2 cc of the first three drug combinations (including 20 mg of morphine -50 mg of ketamine-5 mg of midazolom, the volume of which was increased to 10 cc with distilled water).
The second group received a combination of the second three drugs (including 20 mg of morphine -50 mg of ketamine -50 mg of diphenhydramine, the volume of which is 10 cc with distilled water).
Then, the time of starting the effect of the drug, change of VAS or RICHMOND Agitation Sedation scale, stability of the drug effect in patients, nausea and vomiting, blood pressure and heart rate of patients and in the first time of drug application and drug use are recorded in the first 24 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1- Age 20 to 65 years. 2- Restorative surgery 3- Need for postoperative analgesia
Exclusion criteria: 1-Drug addiction 2- History of heart disease, kidney, liver and glaucoma.3-History of psychotropic drugs and anti-nausea and vomiting
Intervention groups
All elective patients undergo reconstructive surgery
Main outcome variables
The severity of the pain
heart beat
blood pressure
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N2
Registration date:2020-05-26, 1399/03/06
Registration timing:retrospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-11-22, 1398/09/01
Trial completion date
2019-12-22, 1398/10/01
Scientific title
Analgesic effect of combining Midazolam, Morphine and Diphenhydramine for acute postoperative pain management, A comparative study
Public title
Analgesic effect of combining Midazolam, Morphine and Diphenhydramine for acute postoperative pain management, A comparative study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are extubated after surgery and recover. In recovery, patients were evaluated based on VAS or Richmond criteria, and if they had a VAS> 4 score or Richmond +2 and above, they entered the study and were randomly assigned to one of the two groups.
Exclusion criteria:
opioids addiction, underlying ischemic cardiac diseases, renal function and liver function diseases, history of allergic reaction to any of the medications used, and use of any antiemetic and antipsychotic medications, PONV and glaucoma.
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling is done by easy burst method and according to patient referral to recovery room.
Randomization method is balanced block randomization and will be done by Randlist software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who makes the medicine add a code to every single medicine .
The person who injects the drug does not know the code.
The patient is not aware of the type of injectable medication.
The researcher is not aware of the type of drug during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ،tehran University of Medical Sciences
Street address
sina hospital, imam khomeini st.
City
tehran
Province
Tehran
Postal code
1136746911
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.224
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
S66.0
ICD-10 code description
Injury of long flexor muscle, fascia and tendon of thumb at wrist and hand level
Primary outcomes
1
Description
The effect of the drug combination of midazolam, diphenhydramine and morphine on pain relief
Timepoint
In 5, 10, 15, 30 minutes after the operation, the severity pain was measured
Method of measurement
visual analog scal
Secondary outcomes
1
Description
patients' agitation evaluation
Timepoint
In 5, 10, 15 and 30 minutes after surgery
Method of measurement
richmond agitation scale
Intervention groups
1
Description
Intervention group: Morphine, Midazolam, In this group, in a syringe of 10 cc, 10 mg of morphine, 100 mg of diphenhydramine and 10 mg of midazolam,prepared then increase the volume to 10 cc with distilled water.In patients who have pain and want to take analgesia, we inject one cc of this medicine mixture. Two minutes after the injection, if the pain is not controlled, we take another cc of this mixture. we record the number of injections and reduce the severity of the pain and the duration of the pain reduction per minute.
Category
Treatment - Drugs
2
Description
Control group: Morphine, ketamine, Diphenhydramine.In this group, in a syringe of 10 cc, 10 mg of morphine, 100 mg of diphenhydramine and 10 mg of ketamine,prepared then increase the volume to 10 cc with distilled water.In patients who have pain and want to take analgesia, we inject one cc of this medicine mixture. Two minutes after the injection, if the pain is not controlled, we take another cc of this mixture. we record the number of injections and reduce the severity of the pain and the duration of the pain reduction per minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
sina hospital
Full name of responsible person
mohammadreza khajavi
Street address
sina hospital, imam khomeini st.
City
tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammad ali sahraeian
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available