Comparing the effect of intravenous midazolam and oral melatonin on controlling agitation caused by ketamine in emergency department
Design
Prospective clinical trial with parallel control group, double-blind, randomized with the table of random numbers
Settings and conduct
In this study, 96 patients who are candidate for receiving Ketamine in emergency department of Al-Zahra and Kashani hospitals in Isfahan are divided into three groups using randomized blocking method. The drugs are prepared and packaged by the pharmacology department. The first group is treating with intravenous midazolam and oral placebo and the second group is treated with oral melatonin and intravenous placebo. The third group is control group that is treated with oral and intravenous placebo. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous Ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous Ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg).
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients who aged more than 18 years who are the candidate for receiving Ketamine as an anesthesia for small surgeries. Exclusion criteria: Patients with fever, obesity, head trauma, hydrocephaly, glaucoma, and psychological disorders.
Intervention groups
In this study all patients are receiving intravenous Ketamine as an anesthesia. Patients in the first group are receiving intravenous Midazolam and oral placebo, 30 minutes before receiving Ketamine. Patients in the second group are receiving oral Melatonin and intravenous placebo, 30 minutes before receiving Ketamine. Patients in the third group are receiving oral and intravenous olacebo, 30 minutes before receiving Ketamine.
Main outcome variables
Richmond Agitation Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N8
Registration date:2018-09-24, 1397/07/02
Registration timing:retrospective
Last update:2018-09-24, 1397/07/02
Update count:0
Registration date
2018-09-24, 1397/07/02
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
2018-03-21, 1397/01/01
Scientific title
Comparing the effect of intravenous midazolam and oral melatonin on controlling agitation caused by ketamine in emergency department
Public title
Reduction of agitation associated with ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Receiving ketamine as an anesthetic agent for small surgeries
Patient's consent to participate in the study
Exclusion criteria:
Fever
Obesity (BMI>30)
Head trauma with loss of consciousness
Brain tumor,
Hydrocephaly
Glaucoma
Psychosis
Psychological disorders
History of using Benzodiazepine during last two weeks
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
After the arrival of the patients to the emergency department, they are divided into 3 groups by a computer-generated random number table with 4 blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
To make sure of the double-blind protocol of the study, preparation of the solutions, injections, and registration of the results were carried out by the pharmacology department. The packets were named A, B, and C following the codes. In one packet, there are intravenous midazolam and oral placebo, in the second packet, there is an equal volume of intravenous placebo and the oral melatonin, and in another packet, there is intravenous and oral placebo. Patients are randomized to receive one of the packets. The patients and their parents and the nurses are unaware of the contents of the drugs. Data collectors, outcome assessors, and data analysts are all kept blinded to the allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.MUI.REC.1396.30.33
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Richmond Agitation Scale score
Timepoint
Every 5 minutes after ketamine administration
Method of measurement
Richmond Agitation Scale table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group patients are receiving 0.05 mg/kg intravenous midazolam (slow infusion) and one placebo tablet, 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg).
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group patients are receiving 0.3 mg/kg oral melatonin and 2 ml intravenous placebo (distilled water), 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg).
Category
Treatment - Drugs
3
Description
Control group: In this group patients are receiving one oral placebo tablet and 2 ml intravenous placebo (stilled water), 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Saeed Majidinejad
Street address
Alzahra hospital, Sofe Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Saeedmajidinejad@yahoo.com
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Saeed Majidinejad
Street address
Kashani hopital, Kashani Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
saeedmajidinejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou Javanmard
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Botshekan
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan CIty
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
saeedmajidinejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Majidinejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
saeedmajidinejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Majidinejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
saeedmajidinejad@yahoo.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
Not applicable
Informed Consent Form
No - There is not 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