Effect of low dose ketamine on pain control in patients with opioid-resistant in acute coronary syndrome or with unstable hemodynamics referred to the emergency department of Shahid Rajaei Hospital in Karaj in 2020-2021
Design
140 patients with a diagnosis of acute opioid-resistant coronary syndrome or with unstable hemodynamics referred to the emergency department of Rajaei Hospital in Karaj will be examined and admitted according to the inclusion and exclusion criteria.Then for patients in both groups after standard treatment in the intervention group intravenous ketamine with a dose of 0.1-0.3 mg / kg and repeated as a bolus and 20 minutes later. For the control group opioid is prescribed with the same dose .
Settings and conduct
This study is such that patients who are candidates for inclusion in the study, after examination in terms of inclusion and exclusion criteria and obtaining informed consent using Block Randomization and software will be divided into two groups 1-intervention and 2-control and Based on the random serials produced
Blinding:
The method of blinding is that the five-digit serial numbers produced in the process of random allocation are placed in sealed envelopes and assigned by an independent person from the research team and by telephone to each of the eligible individuals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age over 18 years
- Age under 65 years
Exclusion criteria:
- Age less than 18 years
- Age over 65 years
Intervention groups
Intervention group: A group of patients receiving low-dose ketamine as part of treatment (0.1-0.3 mg / kg)
Control group: A group of patients who do not receive low-dose ketamine as part of treatment.
Main outcome variables
__________________________________________
Determination of pain relief in patients with acute opioid-resistant coronary syndrome or unstable hemodynamics in the intervention group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190611043864N1
Registration date:2020-12-30, 1399/10/10
Registration timing:registered_while_recruiting
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Ali Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3224 8154
Email address
ali23686@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-14, 1399/06/24
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Low-dose ketamine effectiveness in acute coronary syndrome with opioid unresponsive or hemodynamically unstable patients
Public title
Low-dose ketamine effectiveness in acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-Age above 18 years old
-Age below 65 years old
-Satisfaction for participating in study
-Patients with acute coronary syndrome that has VAS more or equal to 9 and unstable haemodynamic (Systolic blood pressure less than or equal to 90 mm Hg or diastolic blood pressure less than or equal to 60 mm Hg or both)
-Lack of precedent of sensitiveness to ketamine
Exclusion criteria:
-Dissatisfaction for participating in study
-Age below than 18 years old
-Age above than 65 years old
-Weight below than 40 Kg
-Drug or alcohol intoxication
-Active psychiatric disorder
-Heart rate more than 100 per minute
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are readily available in the study (recruitment) and are divided into two groups of intervention and control based on random allocation (random block).
Block Randomization method using the site (https://www.sealedenvelope.com/simple) has been used to assign samples to the intervention and control groups. 35 blocks of 4 with a specific code are prepared and used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding is that the five-digit serial numbers produced in the process of random allocation are placed in sealed envelopes and assigned by an independent person from the research team and by telephone to each of the eligible individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Alborz University of Medical Sciences
Street address
unit4,No42,17th shahrivar ave,shahid Beheshti st
City
Karaj
Province
Alborz
Postal code
3134915964
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.ABZUMS.REC.1399.104
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I60-I69
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Pain
Timepoint
0-15 minutes -30 minutes -45 minutes
Method of measurement
10-visual analogue scale (VAS) - by the patient
2
Description
The amount of pethidine consumed
Timepoint
0, 15, 30, 45 minutes
Method of measurement
Based on milligram of drug used. observe and record files
3
Description
Confusion
Timepoint
0, 15, 30, 45 minutes
Method of measurement
History and physical examination
4
Description
heart rate
Timepoint
0, 15, 30, 45 minutes
Method of measurement
physical examination
5
Description
Systolic blood pressure
Timepoint
0, 15, 30, 45 minutes
Method of measurement
sphygmomanometer cuff based on millimeter of Hg
6
Description
Diastolic blood pressure
Timepoint
0, 15, 30, 45 minutes
Method of measurement
sphygmomanometer cuff based on millimeter of Hg
7
Description
Drowsiness
Timepoint
0, 15, 30, 45 minutes
Method of measurement
History and physical examination
8
Description
Vertigo
Timepoint
0, 15, 30, 45 minutes
Method of measurement
History and physical examination
9
Description
Fatigue
Timepoint
0, 15, 30, 45 minutes
Method of measurement
History and physical examination
10
Description
Headache
Timepoint
0, 15, 30, 45 minutes
Method of measurement
History and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of patients receiving low-dose ketamine as part of treatment (0.1-0.3 mg / kg)
Category
Treatment - Drugs
2
Description
Control group: A group of patients who do not receive low-dose ketamine as part of treatment (0.1-0.3 mg / kg)