This study conductes to comparison of Sublingual Buprenorphine and IV Ketorolac Analgesic Effect in Patients with Renal Colic Present to Emergency Department.This study is a double-dummy, comparisonal randomized clinical trial. Inclusion Criteria:
patient with both gender؛ Age through 18-55 years old؛ Severity pain of renal colic in Visual Pain Analog Scale must be 3-10.
Clnical Criteria: Nephrolithiasis history؛ Severity pain in loin region , Dysuria, Laboratory Criteria: Urinary Analysis (+)
Imaging Criteria: Confirm of stone with Computed Tomography without contrast or sonography.
Exclusion Criteria:
Decreased level of consciousness؛ Cardiac problems؛ Chronic Renel diseases؛ Hepatic and Respiratory diseases؛ Allergy to Opioieds؛ Resiving of analgesic drug in passed 6 hours؛ History of seizure؛ Pregnancy؛ Addiction؛ Abdominal tenderness؛ History or active Gastrointestinal Bleeding. The samples selecte from pateints with renal colic that present to emergency department of Ahvaz Golestan hospital. The time consume of this study is 3 months and 62 peoples enrolle for working. Drug intervention carry out in two groups as each group, resives drug and placebo. Group1: sublingual buprenorphine (tab 0.4 mg) with IV sterile water (placebo) and Group2: IV ketorolac (30 mg) with sublingual placebo. At 0, 20, 40 and 60 minutes after administration,from patient, aske to rate their pain from 0- 10 scales.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041421773N1
Registration date:2015-05-09, 1394/02/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-05-09, 1394/02/19
Registrant information
Name
Marzieh Dezham
Name of organization / entity
Assistant Professor of Emergency Medicine
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 9012
Email address
dezham.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondishapour University of Medical Sciences, Mdicine Faculty, Department of Assistance Research
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Sublingual Buprenorphine and IV Ketorolac Analgesic Effect in Patients with Renal Colic Presented to Emergency Department
Public title
The comparison of Buprenorphine and Ketorolac Analgesic Effect in Patients with Renal Colic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
patient with both gender؛ Age through 18-55 years old؛ Severity pain of renal colic in Visual Pain Analog Scale must be 3-10.
Clnical Criteria: Nephrolithiasis history؛ Severity pain in loin region , Dysuria, Laboratory criteria: Urinary Analysis (+)
Imaging Criteria: Confirm of stone with Computed Tomography without contrast or sonography.
Exclusion Criteria:
Decreased level of consciousness؛ Cardiac problems؛ Chronic Renel diseases؛ Hepatic and Respiratory diseases؛ Allergy to Opioieds؛ Resiving of analgesic drug in passed 6 hours؛ History of seizure؛ Pregnancy؛ Addiction؛ Abdominal tenderness؛ History or active Gastrointestinal Bleeding.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapour University of Medical Sciences - Ethics Committee
Clinical examination, Observation and asking from patient
Intervention groups
1
Description
Drug intervention carry out in two groups as each group, resives drug and placebo. Group1: sublingual buprenorphine (tab 0.4 mg) with IV sterile water (placebo)
Category
Treatment - Drugs
2
Description
Drug intervention carry out in two groups as each group, resives drug and placebo. Group2: IV ketorolac (30 mg) with sublingual placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Ahvaz hospital, Emergency department
Full name of responsible person
Dr. Javad Mozafari
Street address
Golestan Ahvaz hospital, Emergency department
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Assistance Research- Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Nadre Saki
Street address
Department of Assistance Research of medical faculty- Jundishapour university of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Assistance Research- Jundishapour 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
Emergency Department- Medicine faculty- Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Javad Mozafari
Position
Specialist in Emergency Medicine/ faculty member
Other areas of specialty/work
Street address
Emergency Department- Medicine faculty- Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
mozafari.taha@yahoo.comdezham58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emergency Department- Medicine Faculty- Jundishapour University of Medical Sciences
Full name of responsible person
Dr. javad Mozafari
Position
Specialist in Emergency Medicine/ Faculty member
Other areas of specialty/work
Street address
Emergency Department- Medicine Faculty- Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
mozafari.taha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emergency Department- Medicine faculty- Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Javad Mozafari
Position
Specialist in Emergency Medicine/ Faculty member
Other areas of specialty/work
Street address
Emergency Department- Medicine faculty- Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
mozafari.taha@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)