Objectives: To assess the effect of oral ketamine versus placebo on pain relief in patients with renal colic.
Design: A double blinded randomized clinical trial.
Setting and conduct: The eligible patients with renal colic who will refer to Shahid Beheshti Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) having renal colic; (b) age of 18 to 60 years.
Exclusion criteria: (a) having psychological or personality disorder; (b) pregnancy or breastfeeding; (c) having cardiovascular diseases, hypertension, epilepsy, glaucoma, or diabetes.
Intervention: Intramuscular injection of pethidine 1 mg/kg to maximum of 100 mg plus a single dose of 5 mg/kg oral ketamine 0.5%.
Control: Intramuscular injection of pethidine 1 mg/kg to maximum of 100 mg plus a single dose of 0.1 mg/kg oral glucose 5%.
Primary outcome: Severity of pain using Visual Analog Scale before and 3 hours after intervention.
Secondary outcome: (a) severity of nausea using Four Point Scale before and 3 hours after intervention; (b) number of vomiting with question before and 3 hours after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410319014N46
Registration date:2014-11-01, 1393/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-01, 1393/08/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-04-26, 1392/02/06
Expected recruitment end date
2013-06-07, 1392/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral ketamine versus placebo on pain relief in patients with renal colic: a double blinded randomized clinical trial
Public title
Effect of oral ketamine versus placebo on pain relief in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having renal colic; (b) age of 18 to 60 years.
Exclusion criteria: (a) having psychological or personality disorder; (b) pregnancy or breastfeeding; (c) having cardiovascular diseases, hypertension, epilepsy, glaucoma, or diabetes.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be allocated to intervention and control groups through block randomization. For this purpose, patients will be divided into groups of four then each group will be allocated to intervention and control groups 2 by 2.
Blinding: The patients in the intervention and control groups will receive drug with the same volume and color. Therefore, they will not aware of the intervention. In addition, the examiner will not aware of the type of intervention. Accordingly, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
D/P/16/35/9/2887
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
severity of pain
Timepoint
before and 3 hours after intervention
Method of measurement
using Visual Analog Scale
Secondary outcomes
1
Description
severity of nausea
Timepoint
before and 3 hours after intervention
Method of measurement
using Four Point Scale
2
Description
number of vomiting
Timepoint
before and 3 hours after intervention
Method of measurement
with question
Intervention groups
1
Description
Intramuscular injection of pethidine 1 mg/kg to maximum of 100 mg plus a single dose of 5 mg/kg oral ketamine 0.5%
Category
Treatment - Drugs
2
Description
Intramuscular injection of pethidine 1 mg/kg to maximum of 100 mg plus a single dose of 0.1 mg/kg oral glucose 5%.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Maedeh Hassani
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Maedeh Hassani
Position
Medical student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+81 38380704
Fax
Email
msh6440@gmai.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Shahriar Amihassani
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0704
Fax
Email
shahriar-amirhassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)