The aim of the study is evaluation of analgesic effect of ketamine in renal colic patients. This is a randomized double blind clinical trial and all patient who come to emergency department with acute renal colic ( diagnosed by past history and clinical sign) and signed inform consent form and have not exclusion criteria of the study( unwilling to study participation, drug allergy) , include to the trial. The study population is 25 patients in each group. With block randomization each patients allocated to one of two groups. Group 1, receive 1 mg/kg intranasal ketamine as analgesic and intravenous sodium chloride solution as placebo and group2, receive 0.1 mg/kg intravenous morphine as analgesic and intranasal sodium chloride solution as placebo. At the beginning of study and after 15 and 30 min of intervention we calculate pain level of patients with using of visual analog scale. We use 0.75 mcg/kg fentanyl as rescue analgesic if, 1- persistent pain after 30 min 2- changing in VAS score < 13 mm 3- patients willing
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412208872N8
Registration date:2015-01-18, 1393/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-01-04, 1393/10/14
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intranasal ketamine and intravenous morphine in patients with renal colic
Public title
analgesic effect of intranasal ketamine in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patient with high clinical suspicious of renal colic; all patient who come with pain and have clinical or lab data of renal colic.
Exclusion criteria: age < 15 years; unwilling to study participation; past history of allergy to morphine or ketamine; pregnancy; history of analgesic drug consumption < 6 hours ago; peritoneal sign; liver; renal or heart failure patients; decrease level of consciousness; mental disability
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran University of Medical Sciences
Street address
No. 1, North door of Tehran university, Poursina street, Enghelab street
City
Tehran
Postal code
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
93/ص/130/1997
Health conditions studied
1
Description of health condition studied
urolithiasis
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
pain due to urolithiasis
Timepoint
0, 15, 30 min
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
side effects
Timepoint
during discharge
Method of measurement
quessionary
2
Description
patients satisfaction
Timepoint
during discharge
Method of measurement
quessionary
Intervention groups
1
Description
Group 1: receive 1 mg/kg intranasal ketamin as analgesic and intravenous sodium chloride solution as placebo. We use 0.75mcg/kg fentanyl as rescue analgesic if, 1- persistent pain after 30 min 2- changing in VAS score < 13mm 3- patients willing
Category
Treatment - Drugs
2
Description
group2, receive 0.1 mg/kg intravenous morphine as analgesic and intranasal sodium chloride solution as placebo. We use 0.75mcg/kg fentanyl as rescue analgesic if, 1- persistent pain after 30 min 2- changing in VAS score < 13mm 3- patients willing
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Alireza Jalali
Street address
Sina Hospital, Hsan Abad Square, Imam Khomeini Street
City
Tehran
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Morteza Saeedi
Street address
Shariati Hospital, North Amirabad Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
No.1, North door of Tehran university, Poursina street, Enghelab stree
City
Tehran
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
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Morteza Saeedi
Position
Assistant Professor/ Emergeny Medicine Specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
m_saeedi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Morteza Saeedi
Position
Assistant professor/ Emergeny Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
m_saeedi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Morteza Saeedi
Position
Assistant Professor/ Emergeny Medicine Specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
00
Fax
Email
m_saeedi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)