Comparison of Sub-dissociative dose of ketamine and morphine sulfate for acute pain control of patients with isolated limb injuries in the emergency department
Comparison of sub-dissociative dose of ketamine and morphine sulfate for acute pain control of patients with isolated limb injuries in the emergency department
This study will be conducted in Imam Khomeini Hospital in Tehran, Iran, which is an academic hospital. This will be a triple blinded randomized clinical trialThe emergency department sees 70000 patients annually. Patients, the committee that monitors the response variable, and the analyzer will be blinded. All randomizations and drug preparations will be done by a single investigator who will not participate in patients enrollment, assessment, and analysis. Patients with isolated limb trauma who has pain intensity equal to or greater than 5 of 11 on NRS will receive intravenous morphine or ketamine randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Emergency department patients with isolated traumatic limb injuries with a pain score of 5 or more on a standard 11-point (0-10) numerical rating scale
Exclusion criteria: Patients with altered mental status, Patients with unstable vital signs, Patients with known underlying hepatic or renal diseases, Pregnant patients, Non-consent patients, and Patients under the age of 18 or over the age of 55 years old
Intervention groups
The first intervention group: 0.1 mg/kg ketamine in 10 mL normal saline over 5 minutes intravenously.
The second intervention group: 0.05 mg/kg morphine in 10 ml normal saline over 5 minutes intravenously.
Main outcome variables
Pain intensity; adverse events.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150213021063N6
Registration date:2020-07-20, 1399/04/30
Registration timing:retrospective
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
Registrant information
Name
Arash Safaie
Name of organization / entity
Tehran University of Medical Scieces- Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 216312413
Email address
a-safaie@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2017-01-20, 1395/11/01
Trial completion date
2017-01-20, 1395/11/01
Scientific title
Comparison of Sub-dissociative dose of ketamine and morphine sulfate for acute pain control of patients with isolated limb injuries in the emergency department
Public title
Ketamine versus morphine for acute pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Emergency department patients with isolated traumatic limb injuries with a pain score of 5 or more on a standard 11-point (0-10) numerical rating scale
Exclusion criteria:
Patients with altered mental status
Patients with unstable vital signs
Patients with known underlying hepatic or renal diseases
Pregnant patients
Non-consent patients
Patients under the age of 18 or over the age of 55 years old
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
73
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be performed using random numbers table. The random numbers table itself will be made by the http://random.org website. The drugs will be prepared in blocks of similar looking 10 mL syringes allocated to the 2 intervention groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All randomizations and drug preparations will be done by a single investigator who will not participate in patients enrollment, assessment, and analysis. The other investigators and patients will be blinded. Also the committee that monitor response variable will be blinded.
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
Building No 1- Northern gate of the university- Poursina street- Qods street- Enghelab avenue.
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
IR.TUMS.REC.1394.1710
Health conditions studied
1
Description of health condition studied
Acute pain due to trauma
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain intensity
Timepoint
Before drug administration, 5, 10, 15, 20, 25, and 30 minutes after drug administration
Method of measurement
Numeric rating scale
Secondary outcomes
1
Description
Adverse events
Timepoint
Patients will be monitored continuously for adverse events since drug administration till patient discharge.
Method of measurement
Specific occurred adverse event
Intervention groups
1
Description
Intervention group: 0.1 mg/kg ketamine in 10 mL normal saline over 5 minutes intravenously
Category
Treatment - Drugs
2
Description
Intervention group: 0.05 mg/kg morphine in 10 ml normal saline over 5 minutes intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Seyed Mojtaba Aghili
Street address
Chamran Highway, Baqerkhan Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Building No 1- Northern gate of the university- Poursina street- Qods street- Enghelab avenue.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6641 8466
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?