In randomized, double-blind study patient between 18 to 50 years old with nephrolithiasis and severe renal colic be visited to one of the hospitals that are affliated to Tehran University accidently they are divided to two categories. One group with morphine plus placebo (mp) and the other group with morphine plus ketamine (mk) prescribed. The patients have inclusion criteria will be accepted and exclusion criteria will not. All patients were assessed for pain by using VAS chart. One group received Morphine ( 0.1 mg/kg intravenous ) and placebo, and another group received morphine with the same dose and ketamine (0.1 mg/kg/dose intravenous , maximum dose = 0.4 mg/kg).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109297667N1
Registration date:2012-03-14, 1390/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-14, 1390/12/24
Registrant information
Name
Nader Bidi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
n-bidi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of medical sciences
Expected recruitment start date
2012-02-26, 1390/12/07
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Low dose Ketamin plus Morphine versus Morphine alone in acute pain management of severe renal colic
Public title
Effect of ketamine and morphine in pain management of renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Previous nephrolithiasis , age between 18 to 50 years old, severity of pain at least 6 from 10, systolic blood pressure >= 90 mmHg, heart rate = 60-120/m, respiratory rate = 8-22/m, o2sat >= 90%, no addiction to opiate or psychiatric drugs, no use analgesic drugs or opioid before recording the data, no history of chronic liver disease or kidney or respiratory disease, no history of coagulopathy or blood disorders or chronic psychiatric disorder, no use of psychiatric drugs.
Exclusion criteria:
The patient who is not interested in study, addiction to opiate or psychiatric drugs, allergy to morphine or ketamine, inability to perception of VAS
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Hemmat highway,Tehran
City
Tehran
Postal code
Approval date
2012-02-25, 1390/12/06
Ethics committee reference number
2315
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Severity of pain
Timepoint
Before prescription the medication, 10, 30, 60, 90 and 120 minutes after medication
Method of measurement
VAS ( visual analog scale)
Secondary outcomes
1
Description
nausea
Timepoint
Before prescription the medication, 10, 30, 60, 90 and 120 minutes after medication
Method of measurement
Questionnaire
2
Description
agitation
Timepoint
Before prescription the medication, 10, 30, 60, 90 and 120 minutes after medication
Method of measurement
Questionnaire
3
Description
diplopia
Timepoint
Before prescription the medication, 10, 30, 60, 90 and 120 minutes after medication
Method of measurement
Questionnaire
4
Description
hallucination
Timepoint
Before prescription the medication, 10, 30, 60, 90 and 120 minutes after medication
Method of measurement
Questionnaire
Intervention groups
1
Description
One group received morphine 0.1 mg/kg intravenous and ketamine (0.1 mg/kg/dose intravenous , maximum dose = 0.4 mg/kg),
Category
Treatment - Drugs
2
Description
another group received Morphine ( 0.1 mg/kg intravenous ) and placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Hazrat Rasool hospital
Full name of responsible person
Dr. Bdi nader
Street address
Sattarkhan St., Niaiesh
City
Tehran
2
Recruitment center
Name of recruitment center
Emergency department of Sina hospital
Full name of responsible person
Dr. Bidi nader
Street address
Imam Khomeini Sq, Hasan abad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences-Deputy for research affairs
Full name of responsible person
Dr akhondzadeh shahin
Street address
Tehran-keshavarz St-porsina St-tehran university-Deputy for research affairs
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-Deputy for research affairs
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. Bidi nader
Position
MD
Other areas of specialty/work
Street address
Hazrat Rasool hospital, Sattarkhan, Niaiesh
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
n-bidi@razi.tums.ac.ir; bidi.nader@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Abbasi saeeid
Position
Assistant professor
Other areas of specialty/work
Street address
Sattarkhan St., Niaiesh, Hazrat Rasool hospital,emergency department
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
saieedabbasi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hazrat Rasool hospital, Sattarkhan, Niaiesh
Full name of responsible person
Dr. Bidi nader
Position
MD
Other areas of specialty/work
Street address
Hazrat Rasool hospital, Sattarkhan, Niaiesh
City
Tehran
Postal code
Phone
+98 939 057 2566
Fax
Email
n-bibi@razi.tums.ac.ir; bidi.nader@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)