Efficacy of intravenous paracetamol versus intravenous morphine and intravenous ketorolac in controlling renal colic in emergency ward patients of Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences
Patients with flank pain diagnosed as renal colic confirmed by sonography or spiral CT scan are entered in this study. Patients are divided in 3 groups: case group (receiving intravenous apotel), control group (receiving intravenous morphine) and third group receiving 30 mg intravenous ketorolac. A questionnaire containing demographic data, diagnosis, sonographic or CT scan findings. Inclusion and exclusion criteria are recorded and severity of pain is defined by visual or verbal criteria. The nurse administers the medications randomly and 1`st dose is given and after 30 minutes the pain is checked according to verbal or visual pain assessment scale; if pain is not decreased, then a dose of rescue analgesic (fentanyl) is given. The patients are observed for 6 hours in surgical emergency ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072110330N1
Registration date:2013-04-18, 1392/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-18, 1392/01/29
Registrant information
Name
Seyed Ashkan Tabibzadeh
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 1333 7192
Email address
dr.atabibzadeh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences, researech department
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intravenous paracetamol versus intravenous morphine and intravenous ketorolac in controlling renal colic in emergency ward patients of Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences
Public title
Efficacy of intravenous paracetamol versus intravenous morphine and intravenous ketorolac in controlling renal colic in emergency ward patients of Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: symptoms of renal colic verified by sonograhy or spiral CT scan. Exclusion criteria: allergy; suspected ruptured abdominal aortic aneurysm; history of hepatic or renal insufficiency; liver or kidney transplant; history of asthma; dialysis; hemodynamic instability; suspected pregnancy; fever more than 38 celsius orally; peritoneal irritation; use of parenteral analgesic 6 hours PTA.
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences Ethics Committee
Street address
Ostandari Blvd, Hormozgan University of Medical Sciences
City
Bandar-e-Abbas
Postal code
7919915519
Approval date
2013-02-27, 1391/12/09
Ethics committee reference number
H-E-C-9-1-12-1
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N20-23
ICD-10 code description
Calculus of urinary tract
Primary outcomes
1
Description
Pain
Timepoint
Before pain onset or 15-30 mins after onset
Method of measurement
Verbal and visual
2
Description
Pain relief
Timepoint
30 minutes after intervention
Method of measurement
Verbal or visual pain assessment scale
Secondary outcomes
empty
Intervention groups
1
Description
Group 3: morphin sulfate 10mg IV infusion in 100cc normal saline 0.9%
Category
Treatment - Drugs
2
Description
Group 1: paracetamol iv infusion in 100cc normal saline 0.9% over 15 minute
Category
Treatment - Drugs
3
Description
Group 2: ketoroac 30 mg IV infusion in 100cc normal saline 0.9% over 15 mintue
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department, Shahid Mohamadi hopspital
Full name of responsible person
Dr Ashkan Tabibzadeh
Street address
Jomhouri boulevard, Shahid Mohamadi hospital
City
bandar abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resarch department, hormozgan university of medical sciences
Full name of responsible person
Dr Abdolazim Nejatizadeh
Street address
Jomhouri Boulevard, Shahid Mohamadi hospital, Research department
City
Bandar abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resarch department, hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Seyed Ashkan Tabibzadeh
Position
Emergency medicine specialist- Head of Emergency ward- Head of Trauma and Eemergency Research Center
Other areas of specialty/work
Street address
Shahid Mohammadi hospital- Emergency ward
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76133470016
Fax
Email
atabibzade@hums.ac.ir; ashkantz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Ashkan Tabibzadeh
Position
Assistaqnt professor of Emergency Medicine
Other areas of specialty/work
Street address
Shahid Mohamadi hospital, Emergency Department
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 1333 7192
Fax
+98 77613337192
Email
atabibzade@hums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Ashkan Tabibzadeh
Position
Emergency Medicine Specialist/ Head of Emergency Department/ Head of Trauma and Emergency Resaerch C
Other areas of specialty/work
Street address
Shahid Mohamadi hospital- Emergency Department
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76133470016
Fax
Email
atabibzade@hums.ac.ir; ashakntz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)