Comparison of the therapeutic effects of intravenous ketamine and intravenous morphine in the treatment of patients with renal colic
Design
The double-blind clinical trial, with parallel groups, randomized. 47 patients In each group, the first group will receive 0.3 mg/kg of intravenous Ketamine and the second group will receive 0.1 mg/kg of intravenous Morphine.
Settings and conduct
The present study will be conducted to compare the analgesia of ketamine with morphine in patients admitted to Imam Khomeini hospital of Ahvaz Jundishapur University of Medical Sciences with renal colic. Patients will be divided into two groups based on a block randomized method. Patients will be blind towards the drugs. Analgesia degree will be registered by the blind researcher.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years with stone-related renal colic (confirmed by imaging) were evaluated, while patients with a history of cardiovascular and hypertension, pregnancy, breastfeeding, history of drug addiction, history of seizure and glaucoma were excluded.
Intervention groups
Patients in the first group will receive 0.3 mg/kg of intravenous Ketamine. In the second group, patients will receive a dose of 0.1 mg/kg of intravenous Morphine.
Main outcome variables
Comparison of analgesia based on VAS criteria in both groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180530039917N2
Registration date:2019-03-05, 1397/12/14
Registration timing:retrospective
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Payam Ghoraian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
ghoraian.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the therapeutic effects of intravenous Ketamine and intravenous Morphine in the treatment of patients with renal colic
Public title
Comparison of Ketamine and Morphine in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
VAS more than 5
Patients with renal colic due to stones (confirmed by imaging)
Exclusion criteria:
History of cardiovascular disease and hypertension
Pregnancy
Breastfeeding
Drug addiction
History of seizure
Glaucoma
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
136
Actual sample size reached:
136
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method (with a block size of four) will be used, and a person unaware of the study objectives will seal the obtained codes in opaque envelopes and then the envelopes will be given to one of the researchers who has no role in the treatment or evaluation. Afterward, the researcher will provide syringes containing the solution base on the confidential codes and will give it to the physician to inject
Blinding (investigator's opinion)
Double blinded
Blinding description
Numbered drugs will be injected muscularly by the medical assistant. The analgesia degree based on the VAS method was registered by a blinded emergency resident.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commite of Jundishapur University of Ahvaz
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6435134551
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.AJUMS.REC.1396.1035
Health conditions studied
1
Description of health condition studied
Renal Colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain level
Timepoint
Before the intervention, 5, 10, 20, 30 and 60 minutes after the intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A single dose of 0.3 mg/kg Intravenous Ketamine
Category
Treatment - Drugs
2
Description
Intervention group: A single dose of 0.1 mg/kg Intravenous Morphine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Reza Nazi
Street address
Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
56143661
Phone
+98 61 2267 4822
Email
ali.khossravi70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 8876 1241
Email
srnaji@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Naji
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
srnaji@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Naji
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
srnaji@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Naji
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
srnaji@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
Not applicable
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