Protocol summary

Study aim
Comparison of ketamine، propofol Versus ketamine،Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation
Design
Randomized clinical trial with two comparative groups, double-blind, simple individual randomization from Random.org, on 90 patients
Settings and conduct
Patients with anterior shoulder dislocation referred to the emergency department of Shahid Sadoughi and Rahnemoun hospitals in Yazd After being diagnosed by a physician, patients are admitted to the study according to the inclusion and exclusion criteria and after initial measures, they are divided into two groups; Group A ketamine, propofol and group B ketamine, thiopental. Reduction occurs when proper sedation is established. Any side effects are considered and appropriate treatment is taken. The person performing the reduction and the patient themselves are not aware of the type of medication; For this purpose, the syringe containing the drug is covered in such a way that the color of the drug is not clear.
Participants/Inclusion and exclusion criteria
Patients aged 18-64 years, those who do not require reduction in the operating room, healthy patients without previous disease, and those with mild systemic disease without functional limitations according to the American Society of Anesthesiologist classification (individuals 1 and 2) and Those who have been (Nil Per Os) NPOs or consumed fluids in the last 3 hours are included in the study.Patients with any contraindications are excluded.
Intervention groups
After injection of ketorolac and midazolam to all patients, they divide randomly into two groups : in group A, ketamine, propofol and in group B, ketamine,thiopental.
Main outcome variables
time to proper sedation، discharge time, The duration of the effect of the drug ،times require additional dose of drug, pain before and during reduction,any side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200809048341N1
Registration date: 2020-11-23, 1399/09/03
Registration timing: prospective

Last update: 2020-11-23, 1399/09/03
Update count: 0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Soheila Azimi Aabarghouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 2682
Email address
s.azimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-28, 1399/09/08
Expected recruitment end date
2021-02-26, 1399/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ketamine /propofol Versus ketamine/Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation
Public title
Comparison of ketamine /propofol Versus ketamine/Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients without previous disease and those with mild systemic disease without functional limitations according to the American Society of Anesthesiologist classification (individuals 1 and 2) Those who have been NPOs ( Nil Per Os) or consumed fluids in the last 3 hours Those that do not need to be reduced in the operating room. Age 18 to 64 years
Exclusion criteria:
Any contraindications including asthma and COPD(chronic obstructive pulmonary disease), systolic blood pressure below 90 or above 180, ischemic heart disease or heart failure, any symptoms in favor of increased intracranial pressure, glaucoma, psychosis and use of any psychotropic substances, acute or chronic alcoholism, liver or kidney failure, Allergies to any of the drugs studied or eggs or soy, people addicted to drugs, taking any sedatives or anesthetics before going to the emergency room, obstructive sleep apnea syndrome, maxillofacial malformations that block the airway, Pregnancy, dislocations lasting more than 24 hours, multiple trauma or hemodynamic instability, history of uncontrollable seizures, and patients who do not wish to participate in the study
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization: Based on a random sequence of numbers from Random.org, a table will be prepared, with the first forty-five consecutive numbers in Group A and the next forty-five consecutive numbers in Group B.These numbers will be assigned to each patient in order of referral.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person performing the reduction and the patient themselves do not know the type of medicine; For this purpose, the syringe containing the drug is covered in such a way that the color of the drug is not clear
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Medicine _ Shahid Sadoughi University of Medical Sciences
Street address
Central building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
89416978477
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.021

Health conditions studied

1

Description of health condition studied
Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation
ICD-10 code
S43.0
ICD-10 code description
Subluxation and dislocation of shoulder joint

Primary outcomes

1

Description
Time to appropriate sedation
Timepoint
3 minutes after the last drug injection
Method of measurement
physical examination

2

Description
The duration of the effect of the drug
Timepoint
15 minutes after drug injection
Method of measurement
Physical examination

3

Description
Discharge time
Timepoint
15 minutes after drug infection
Method of measurement
Physical examination

4

Description
The pain before reduction
Timepoint
before starting reduction
Method of measurement
By the visual analog scale

5

Description
Need to additional doses of medication
Timepoint
3 minutes after the last injection
Method of measurement
Physical examination

6

Description
Incidence of any side effects
Timepoint
Before injecting the drug and every 5 minutes
Method of measurement
Physical examination and vital signs

7

Description
Pain during reduction
Timepoint
During reduction
Method of measurement
By the facial pain scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: First, we inject 30 mg of ketorolac intravenously in all patients for 30 minutes 15 minutes before prescribing other drugs. We then inject 1 mg of midazolam intravenously into all patients. Then from the combination of ketamine / propofol (ketamine 1 mg per kg body weight (maximum 50 mg) and propofol 1 mg per kg body weight (maximum 50 mg) intravenously and slowly for 30-60 seconds) Used. If sedation does not occur in this group within 3 minutes, half the dose of the first medication is repeated. If, after injecting the initial dose, after receiving two and a half doses of the drug, proper sedation does not occur or the reduction is not successful, sedation is considered a failure and orthopedic consultation is requested. Appropriate sedation is determined by the RASS score (Richmond Agitation and Sedation Scale); We start reduction when the patient has a RASS score of -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of ondansetron at a dose of 4 mg and in case of hypoxia, apnea or spasm, respectively, head tilt chin lift, oral airway and ambobag breathing, and if none of them were effective, intubation should be used.
Category
Treatment - Drugs

2

Description
Intervention group 2: First, all patients are injected with 30 mg of intravenous ketorolac within 30 seconds 15 minutes before prescribing other drugs. One mg of midazolam is then injected intravenously into all patients. The thiopental / ketamine combination is then used (ketamine 1 mg per kg body weight (maximum 50 mg) and thiopental 2 mg per kg body weight (maximum 100 mg) intravenously and slowly Within 30-60 seconds). If sedation does not occur in this group within 3 minutes, half the dose of the first medication is repeated. If proper sedation does not occur after injecting the initial dose after receiving two half doses, or the reduction is not successful, failure in sedation is considered and orthopedic consultation is requested. Appropriate sedation is determined by the RASS score (Richmond Agitation and Sedation Scale)؛ We start reduction when the patient has a RASS score to -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of ondansetron at a dose of 4 mg and in case of hypoxia, apnea or , spasm, respectively, head tilt chin lift, oral airway and ambobag breathing, and if none of them were effective, intubation should be used.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Soheila Azimi Abarghouei
Street address
Emergency department, Ebne Sina Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Email
S.azimi@ssu.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Rahnemoon Hospital
Full name of responsible person
Soheila Azimi Abarghouei
Street address
Farrokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Email
Z.hajisafaritafti@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masoud mirzaei
Street address
Central building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Email
Info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Hajisafari Tafti
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 9, Shamshad Alley 7, Fatemieh Blvd, Shahid Sadoughi Town
City
Taft
Province
Yazd
Postal code
8991877685
Phone
+98 35 3263 5841
Email
Z.hajisafaritafti@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Soheila Azimi Aabarghouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency ward, Shahid Sadoughi Hospital, Ebne sina Blvd.
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Fax
Email
S.azimi@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Hajisafari Tafti
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 9, Shamshad Alley 7, Fatemieh Blvd, Shahid Sadoughi Town
City
Taft
Province
Yazd
Postal code
8991877685
Phone
+98 35 3263 5841
Email
Z.hajisafaritafti@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
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
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