Evaluation of analgesic effect of Intravenous sub dissociative ketamine and Intravenous fentanyl in adult patients with acute pain, in Emergency Department, Sina Hospital, 1395 - 1398
Evaluation of analgesic effect of Intravenous sub dissociative ketamine and Intravenous fentanyl in adult patients with acute pain, in Emergency Department
Design
We study on 200 patients that admitted in Emergency Room at Sina Hospital because of any acute pain. Intervention group: Prescribing intravenous Ketamine in dose 0.3 mg per kg and Control group: Prescribing intravenous Fentanyl in dose 1 micro gram per kg. Randomization Windows version 6.0 software. The study is in data collection phase.
Settings and conduct
We study on 200 patients that admitted in Emergency Room at Sina Hospital because of any acute pain. We ask them that score the pain from 1 to 10. If the score is above 5 and there is no exclusion criteria then we explain about our study and give them a consent letter. After their consent he or she takes intravenous Ketamine in 0.3 mg per kg or Fentanyl in 1 microgram per kg. Beforehand we have randomized the patients with Block Stratified Randomization Windows version 6.0 software. In this research the patients do not inform about the medication. And the researcher and the follower are not a same person. We documented the patient's demographic information and vital signs and pain score in the collection sheet. After injection the follower ask her or him about the pain score in minutes 5, 10, 15, 30 and document it. Also the follower check the patient's vital signs in these times and document them and the side effects. We will analyze these data.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Any adult patient (age>18) with acute pain who need analgesia in emergency department and the pain score is above 5/10
Exclusion criteria:
Pain score ≤ 5
Pregnancy and post-partum women
Altered mental status
Allergy to ketamine or fentanyl
Body weight ≤ 46 kg or ≥ 115
Unstable vital signs: BP≤ 90 mmHg or ≥ 180 mmHg , PR≥150 or ≤50 bits/min , RR≤10 or ≥30
History of recent head or eye trauma
History of Siesure
History of elevated ICP
Chronic pain
Renal or hepatic failure
Substance or alcohol abuse
Documented psychiatric disorders
Opium addiction
Recent use of narcotic analgesics
Intervention groups
Intervention group: Prescribing intravenous Ketamine in dose 0.3 mg per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10
Control group: Prescribing intravenous Fentanyl in dose 0.1 macro gram per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10
Main outcome variables
pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180130038568N1
Registration date:2018-02-15, 1396/11/26
Registration timing:registered_while_recruiting
Last update:2018-02-15, 1396/11/26
Update count:0
Registration date
2018-02-15, 1396/11/26
Registrant information
Name
Ehsanolah Arabpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
ehsan.tums@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of analgesic effect of Intravenous sub dissociative ketamine and Intravenous fentanyl in adult patients with acute pain, in Emergency Department, Sina Hospital, 1395 - 1398
Public title
Evaluation of analgesic effect of Intravenous Ketamine and Intravenous Fentanyl in adult patients with acute pain, in Emergency Department, Sina Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Any admitted adult patient in Emergency Room
He or she has acute and sever pain
The pain score is above 5/10
Exclusion criteria:
Pain score ≤ 5
Pregnancy and post-partum women
Allergy to ketamine or fentanyl
Body weight ≤ 46 kg or ≥ 115
Altered mental status
Unstable vital signs: BP≤ 90 mmHg or ≥ 180 mmHg , PR≥150 or ≤50 bits/min , RR≤10 or ≥30
History of recent head or eye trauma
History of Siesure
History of elevated ICP
Chronic pain
Renal or hepatic failure
Substance or alcohol abuse
Documented psychiatric disorders
Opium addiction
Recent use of narcotic analgesics
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
with Block Stratified Randomization Windows version 6.0 software
Blinding (investigator's opinion)
Double blinded
Blinding description
with Block Stratified Randomization Windows version 6.0 software. The patient knows that he or she taking intravenous Ketamine or Fentanyl randomly. The researcher and the person that follows patients are not a same person.
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
Pour Sina Ave, Qods St, Enghelab St
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2665
Health conditions studied
1
Description of health condition studied
Acute pain in Emergency Room
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain score
Timepoint
Minute 0, 5, 10, 15, 30
Method of measurement
Scoring 1 to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prescribing intravenous Ketamine in dose 0.3 mg per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10
Category
Treatment - Drugs
2
Description
Control group: Prescribing intravenous Fentanyl in dose 1 micro gram per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Ehsanolah Arabpour
Street address
Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
hosp_sina@sina.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
Qods Ave, Keshavarz Blvd, Central Organozation of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
tums-research@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
Pooya Payandemehr
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Hassan Abad Square, Sina Hospital, Emergency Department
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
pooya_mehr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pooya Payandemehr
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Hassan Abad Square, Sina Hospital, Emergency Department
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
pooya_mehr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsanolah Arabpour
Position
Resident Physician
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Hasan Abad Square
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
Email
Ehsan.tums@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