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Comparison of the efficacy of haloperidol combination with midazolam versus haloperidol ketamine in patients with agitation in emergency room

Protocol summary

Study aim
Comparison of the efficacy of haloperidol combination with midazolam versus haloperidol ketamine in patients with agitation in emergency room
Design
This double blind randomized clinical trial conducted on agitated patients admitted in Emergency ward of Shariati Hospital. Sample size is 70 and each group consist of 35 patients and randomly assigned to each group by a computerized software in according to arrival time. Control group receive iv midazolam 0.05 mg/kg and iv haloperidol 2.5 mg/kg. Intervention group receive 0.5 mg/kg iv ketamine and 2.5 mg iv haloperidol. Then level of tranquilizing, possible complication, RR, BP and Spo2 assessed by AMSS in interval time 0, 5, 15, 30, 69, 90, 120 min and 4 hours after intervention.
Settings and conduct
This study conducted in emergency department of Shariati Hospital in patient who have inclusion criteria of the study during of the study. Person who compete the checklist and analyzer are blind to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All agitated patients > 18 y/o who admitted to emergency ward. Exclusion criteria: Pregnant patients, age < 18 y/o, sever head trauma and suspected ICP rising, history of seizure, shock and unstable vital sign, unwilling to participate in the study, hypoglycemia, hypoxemia, and any other treatable medical condition.
Intervention groups
Group A: will receive 2.5 mg haloperidol and 0.05 mg/kg midazolam Group B: will receive 0.5 mg/kg ketamine and 0.05 mg/kg midazolam
Main outcome variables
The main outcome is level of rationalization by Altered mental state score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120130008872N13
Registration date: 2019-10-23, 1398/08/01
Registration timing: prospective

Last update: 2019-10-23, 1398/08/01
Update count: 0
Registration date
2019-10-23, 1398/08/01
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-20, 1398/08/29
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of haloperidol combination with midazolam versus haloperidol ketamine in patients with agitation in emergency room
Public title
Haloperidol midazolam versus ketamine midazolam in agitated patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All agitated patients above 18 years old and admitted to emergency ward
Exclusion criteria:
Pregnant women age<18 y sever head trauma suspected ICP rising seizure history unwilling to participation in the study hypoglycemia hypoxemia all conditions that have treatable medical condition as a reason for agitation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
patient in order of arrival with a randomization software allocated individually in to separate groups. sample size is 70 and the range of numbers are 1 to 70 and each number belong only to one patient and do not repeat. one group receive midazolam and haloperidol and the other on will receive haloperidol and ketamine.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher allocated the patient to each group( A or B ) in according the arrival time and specific number and then the nurse deliver drugs to the patient. Patients are blinded to type of drugs. Checklist fill by a person who is blinded to type of delivered drug. Data analyzer is also blinded to the type of drug because he or she is blinded to the type to drugs that delivered to group A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, School of Medicine
Street address
Poursina Street, 16 Azar Street, Bolvar Keshavarz Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.532

Health conditions studied

1

Description of health condition studied
agitation
ICD-10 code
agitation
ICD-10 code description

Primary outcomes

1

Description
Agitation level
Timepoint
Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention
Method of measurement
altered mental scale score(AMSS)

Secondary outcomes

1

Description
spo2
Timepoint
Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention
Method of measurement
pulsoxymerer

2

Description
Respiratory Rate
Timepoint
Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention
Method of measurement
numbers per min

3

Description
Blood pressure
Timepoint
Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention
Method of measurement
mmhg

Intervention groups

1

Description
Intervention group: A Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention haloperidol
Category
Treatment - Drugs

2

Description
Control group: B will receive 2.5 mg haloperidol iv and 0.5 mg/kg iv ketamine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Morteza Saeedi
Street address
North Amirabad Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Email
m_saeedi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
Building No 1, North entrance door of Tehran University, Poursina sreet, Qods street, Enghelab street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 6641 8466
Email
s.ahkond@neda.net
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
Morteza Saeedi
Position
Associate professor/ Emergency Medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Email
m_saeedi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Saeedi
Position
Associate professor/ Emergency Medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Email
m_saeedi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Morteza Saeedi
Position
Emergency Medicine Specialist; Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Department, Shariati Hospital, North-Amir abaad, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 4426 3995
Fax
Email
m_saeedi@tums.ac.ir
Web page address

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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The raw data and coded information of the patients participating in the study can be provided
When the data will become available and for how long
In the end of the study and after publication of the results the data will be available and we have plan to preserve data for 10 years
To whom data/document is available
Person with academic position
Under which criteria data/document could be used
In order to conduct and design future study in this field
From where data/document is obtainable
email contact with Mr. Morteza Saeedi; m_saeedi@tums.ac.ir
What processes are involved for a request to access data/document
After confirmation of applicant identity, we will contact him/her by email
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