Protocol summary

Summary
Objectives, Compare the differences in clinical testing pain NRS (along with control respiratory rate, heart rate, paradoxical pulse, body temperature, GCS, talking evaluated) before and after the intervention listed from time to time. (2) Design, Clinical trials (3) Setting and conduct, This study was performed double blind. 260 patients referred to Imam Khomeini and Golestan hospitals with biliary colic to be enrolled. First patients to be seen and physical examination are assessed. They will be recorded in the record patients' vital signs and also before any clinical trial resuscitation equipment will be ready. (4) Participants including major eligibility criteria, Inclusion criteria: 1 - MINIMUM AGE 18 and maximum65 years; 2 -Having pain paunch of evaluation by the physician or assistant emergency medicine as biliary colic diagnose; 3 - Unprecedented of stone of the bladder by National rivalries diagnose. exclusion criteria: 1 - Aaged under 18 and Bali 65 years; 2 - The temperature above 38 ºc; 3 - Allergic to ketorolac and other nsaid; 4 -Sensitivity to transdermal fentanyl gasteroentrology; 5 - Patients that tired King outside; 6 - Treatment of anti-making blood in 4 recent weeks; 7 - History ulcers active during 6 recent months; 8 - The history of the disease of blood planning provider; 9 -Patients with safety system, disease of the hepatitis; 10 - Disease of the renal arteries; 11 - Medical problem, acute heart patients; 12 - Pregnant women; 13 - A history of peptic ulcer and pancratit; 14 - Addicts to drugs, mopper foods or any inhalants something; 15 - Failure to confirm biliary colic diagnosed with sonography; 16 -Any problems normal or abnormal in your skin that may attract medicine the skin affected the "having a lot of hair or skin disease; 17 - Receive any kind of pain medication or mopper foods in 8 hours before entering the emergency room (5) Intervention, Injectable ketorolac for intravenous administration of fentanyl skin patch to measure and evaluate pain in patients (6) main outcome measures (variables), Age, gender, temperature, respiratory rate, pulse, blood pressure, pain

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112725261N1
Registration date: 2016-02-28, 1394/12/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Farhad Zarei Ghanavati
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4470 0424
Email address
zarei.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jundishapur University of Medical Sciences, Golestan Hwy, Ahvaz, Khozestan, Iran
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the efficacy of intravenous ketorolac and fentanyl transdermal patch for pain relief in patients with inflammation of the gallbladder colic attacks
Public title
Evaluation of IV Ketorolac with Fentanyl Transdermal Patch effectiveness in relieving pain in biliary colic attacks
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1 - MINIMUM AGE 18 and maximum65 years; 2 -Having pain paunch of evaluation by the physician or assistant emergency medicine as biliary colic diagnose; 3 - Unprecedented of stone of the bladder by National rivalries diagnose; exclusion criteria: 1 - Aged under 18 and Bali 65 years; 2 - The temperature above 38 ºc; 3 - Allergic to ketorolac and other nsaid; 4 - Sensitivity to transdermal fentanyl gasteroentrology; 5 - Patients that tired King outside; 6 - Treatment of anti-making blood in 4 recent weeks; 7 - History ulcers active during 6 recent months; 8 - The history of the disease of blood planning provider; 9 - Patients with safety system, disease of the hepatitis; 10 - Disease of the renal arteries; 11 - Medical problem, acute heart patients; 12 - Ppregnant women; 13 - A history of peptic ulcer and pancratit; 14 - Addicts to drugs, mopper foods or any inhalants something; 15 - failure to confirm biliary colic diagnosed with sonography; 16 -Any problems normal or abnormal in your skin that may attract medicine the skin affected the "having a lot of hair or skin disease; 17 -Receive any kind of pain medication or mopper foods in 8 hours before entering the emergency room
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 260
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
...
Secondary trial Id
...
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Jondi Shapour University of Medical Sciences Ethics Committee
Street address
Jondi Shapour University Ethics Committee, Jondi Shapour University, Golestan Hwy, Ahwaz, Khozestan, Iran
City
Ahwaz
Postal code
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394.405

Health conditions studied

1

Description of health condition studied
biliary colic
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis

Primary outcomes

1

Description
pain
Timepoint
0 and 30 and 60 min and 3-4 h after intervetion
Method of measurement
Numeric Rating Scale metod

Secondary outcomes

1

Description
Side effects of Ketorolac and Fentanyl
Timepoint
0 and 30 and 60 min and 3-4 h after intervetion
Method of measurement
Vital sign,s

Intervention groups

1

Description
Ketorolac IV 30 mg and Transdermal pach with out drugs (Placebo) to a group of patients given only once .
Category
Treatment - Drugs

2

Description
Transdermal Fentanyl 75 mic/gr and plaebo ampuls for the second group of patients who are prescribed only once
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini and Golestan Hospital
Full name of responsible person
Farhad Zarei Ghanavati
Street address
Emergency department, Emam Khomeini hospital, Emam Khomeini St, Ahwaz, Khozestan, Iran
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University, Golestan Hwy, Ahwaz, Khozestan, Iran
City
Ahwaz
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farhad Zarei Ghanavati
Position
Assitant of emergency medicine
Other areas of specialty/work
Street address
Medical College, Ahvaz Jundishapur University of Medical Sciences,Golestan Hwy, Ahwaz, Khozestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 3161
Fax
Email
zarei.f@ajums.ac.ir
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mohamad Ali Fahimi
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Emergency department, Emam Khomeini Hospital, Emam Khomeini St, Ahwaz, Khozestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 3161
Fax
Email
fahimi76@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farhad Zarei Ghanavati
Position
Assistant of emergency medicine
Other areas of specialty/work
Street address
Emergency department, Emam Khomeini Hospital, Emam Khomeini St, Ahwaz, Khozestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 3161
Fax
Email
zarei.f@ajums.ac.ir
Web page address
www.ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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