Objective: Evaluation of the effects of apotel and normal saline on pain relief, need for narcotics, and side effects among renal colic patients.
Design: A double-blind, block randomized clinical trial.
Study population: Renal colic patients.
Inclusion criteria: Renal colic patients; having weight between 50 and 80 kg; aged between 18 and 50 years.
Exclusion criteria: History of allergy to narcotics or acetaminophen; chills and fever; urinary tract infection based on laboratory findings; history of drug abuse, receiving narcotics or other analgesics during six hours before admission; pregnancy; history of renal, cardiac, respiratory, or hepatic failure; history of renal transplantation; abdominal aortic aneurysm; history of hypertension or hemodynamic instability.
Sample size: 110 cases.
Study intervention: The control group will receive 1 g of IV normal saline with 0.05 mg/kg of IM morphine. The intervention group will receive 1 g of IV apotel with 0.05 mg/kg of IM morphine.
Study outcome: Evaluation and comparison of pain level pre- and 30 minutes post-intervention based on Visual Analogue Scale (VAS) and investigation of side-effects of the administered agents based on a questionnaire in the intervention and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051425507N3
Registration date:2016-05-25, 1395/03/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Ali Serous
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4499
Email address
m-jiriaie@mscstu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effects of apotel to normal saline on pain relief, need for narcotics, and side effects among renal colic patients
Public title
Effectiveness of apotel injection in renal colic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Renal colic patients; having a weight between 50 and 80 kg; aged between 18 and 50 years.
Exclusion criteria: History of allergy to narcotics or acetaminophen; chills and fever; urinary tract infection based on laboratory findings; history of drug abuse, receiving narcotics or other analgesics during six hours before admission; pregnancy; history of renal, cardiac, respiratory, or hepatic failure, history of renal transplantation; abdominal aortic aneurysm; history of hypertension or hemodynamic instability.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization using blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Approval date
2015-05-07, 1394/02/17
Ethics committee reference number
IR.ARAKMU.REC.1394.321
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23.0
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain level
Timepoint
Pre- and 30 minutes post-intervention
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Side-effects of pharmaceuticals, include nausea, vomiting, hypotension, itching and drowsiness.
Timepoint
Half an hour after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group: Renal colic patients will receive 1 g of IV normal saline with 0.05 mg/kg of IM morphine, and their level of pain will be assessed pre- and 30 minutes post-intervention based on Visual Analogue Scale (VAS).
Category
Treatment - Drugs
2
Description
Intervention group: Renal colic patients will receive 1 g of IV apotel (acetaminophen injection made of COMBINO PHARM company) with 0.05 mg/kg of IM morphine, and their level of pain will be assessed pre- and 30 minutes post-intervention based on Visual Analogue Scale (VAS).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Ali Sirous
Street address
Valiasr Hospital- Pyrozi Avenue
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences
Full name of responsible person
Ali Asghar Yaghobi
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street,Shahid Shiroodi Street Arak
City
Arak
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 of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Noshin Golchin
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 21 7758 2743
Fax
Email
Golchien.noshin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)