A Comparison, between the analgesic effects of intravenous morphine sulfate with ketamine regimen, and intravenous morphine sulfate regimen solely,in management of the acute pain in renal colic patients who admitted to the emergency department of Imam Khomeini hospital of Sari in year 1394
This double-blind clinical trial will be done to determine the effect of the combination of morphine and ketamine, in comparison with morphine alone in patients with acute renal colic pain. The inclusion criteria are VAS pain score between 7 and 10. Exclusion criteria a history of opium dependency and taking analgesics during last 6 ours prior to the visit. The study population will be included 200 patients with acute renal colic pain referred to Imam Khomeini Hospital. After getting informed consent from people, participants will be divided into two groups. In the first group, intravenous morphine and ketamine and the second group morphine and normal saline will be precipitated. The VAS pain score will be assessed zero, 20 and 40 minutes after the injection. The criteria for treatment response will be a pain score less than 4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080523517N1
Registration date:2017-04-15, 1396/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Salman Erfanian Irankar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3340 6188
Email address
serfanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2015-09-20, 1394/06/29
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison, between the analgesic effects of intravenous morphine sulfate with ketamine regimen, and intravenous morphine sulfate regimen solely,in management of the acute pain in renal colic patients who admitted to the emergency department of Imam Khomeini hospital of Sari in year 1394
Public title
The effects of intravenous morphine sulfate with ketamine in renal pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with acute renal colic with VAS pain score between 7 and 10.
Exclusion criteria: Pregnancy or probable pregnancy; Breast feeding; Contraindications for Morphine usage; History of opium addiction; Taking any analgesics during last 6 hours prior of admission; Peritoneal signs and symptoms in abdominal examination; History of cardiovascular diseases; Psychosis; Refusal of the patients from the participation.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Jouybar crosssroad
City
Sari
Postal code
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
IR.MAZUMS.REC.94.1719
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
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Respiratory rate
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
Respiratory rate in minute
2
Description
Nausea
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
Positive/negative
3
Description
Vomiting
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
Positive/negative
4
Description
Vertigo
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
Positive/ negative
5
Description
Blood pressure
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
mmHg
6
Description
Rash or hives
Timepoint
Zero, 20 and 40 minute after intervention
Method of measurement
Positive/ negative
Intervention groups
1
Description
Morphine sulfate with 0.1 mg / kg the time of intervention and if necessary 0.05 mg / kg in 20 minute after intervention in both control and experimental groups
Category
Treatment - Drugs
2
Description
Ketamine 0.2 mg/kg before the time of intervention in experimental group
Category
Treatment - Drugs
3
Description
Placebo(normal salin) 5 ml at the time of intervention in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Sari , emergency department
Full name of responsible person
Salman Erfanian Irankar
Street address
Imam khomeina hospital emergency department
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Salman Erfanian Irankar
Position
Resident of emergency medicine
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Sari
Postal code
00981133361700
Phone
+98 11 3336 1700
Fax
+98 915 159 3978
Email
s.erfanian@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hosseininejad
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Sari
Postal code
Phone
+98 11 3336 1700
Fax
Email
mhoseininejad@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Salman Erfanian Irankar
Position
Resident of emergency medicine
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Sari
Postal code
Phone
+98 11 3336 1700
Fax
Email
s.erfanian@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)