The research is a Triple blind RCT held in Besat Hospital that is related to Hamedan University of Medical Sciences.
Patients with Colles' fracture coming to Besat Hospital (after being checked for inclusion and exclusion criteria),are divided randomly into two groups. In first one, they receive 400 milligram Ibuprofen and in second one, they receive 30 milligram Ketorolac: both infused over 30 minutes.
Pain intensity is recorded with Numerical Rating Scale at 10 minutes before and every 30 minutes (up to 2 times) after intervention.
Design
in this research, 150 patients with Colles' fracture coming to Hamedan Besat Hospital ( after being checked for inclusion and exclusion criteria), are included. Parcipitants are devided in 2 groups according to randomized table.
Settings and conduct
this research is held in Emergency Department of Hamedan Besat hospital on visitors with Colles' fracture.
Participants/Inclusion and exclusion criteria
Patients with Colles' fracture and aging between 18 to 45 are included except they have one exlcusion criteria.
Intervention groups
75 patients in group 1 receive infused 400 milligram Ibuprofen and 75 patients in group 2 receive infused 30 milligram Ketorolac ( both over 30 minutes) and pain score and side effects will be compared between them.
Main outcome variables
Pain,
Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160727029109N2
Registration date:2018-06-18, 1397/03/28
Registration timing:retrospective
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
samiramis pourmotabed
Name of organization / entity
UMSHA
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 2713
Email address
s.pourmotabed@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Comparing the effect of Intravenous Ketorolac and Intravenous Ibuprofen on controlling pain of Colles' fractures in 18 - 45 Y/O patients
Public title
The pain management efficacy of IV Ibuprofen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18-45 y
Colles' Fracture
Exclusion criteria:
History of drug abuse
Head trauma
Increases ICP signs
Altered mental status
History of Asthma
History of cardiac problems ( CHF - Ischemia)
Hemodynamic instability
CVA
Allergy to NSAIDs
Pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients, get divided randomly into two groups according to random 5 blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, medical observer and medical recorders are unaware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical sciences
Street address
Rsalat BLV, Besat Hoospital
City
Hamedan
Province
Hamadan
Postal code
6515993466
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
IR.UMSHA.REC.1395.181
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
2
Description of health condition studied
colles fracture
ICD-10 code
S52.53
ICD-10 code description
Colles' fracture
Primary outcomes
1
Description
Pain management and pain scaling according to Numerical Rating scale
Timepoint
10 minutes before drug administration and every 30 minutes for 2 times after it
Method of measurement
Numerical Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ibuprofen infusion receivers
Category
Treatment - Drugs
2
Description
Intervention group: Ketorolac infusion receivers
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Ahmad Hadadian
Street address
Resalat BLVD
City
Hamedan
Province
Hamadan
Postal code
6515993466
Phone
+98 81 3264 0030
Email
samiramispm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samiramis Pourmotabed
Street address
Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
6515993466
Phone
+98 81 3838 0582
Email
samiramispm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samiramis Pourmotabed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Resalat BLVD
City
Hamedan
Province
Hamadan
Postal code
6515993466
Phone
+98 81 3264 0030
Email
samiramispm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samiramis Pourmotabed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Resalat BLVD
City
Hamedan
Province
Hamadan
Postal code
6515993466
Phone
+98 81 3264 0030
Email
samiramispm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samiramis Pourmotabed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Resalat BLVD
City
Hamedan
Province
Hamadan
Postal code
6515993466
Phone
+98 81 3264 0030
Email
samiramispm@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available