The study, a randomized double-blind controlled clinical trial, which will determine the effect of sublingual buprenorphine on pain of renal colic in patients with acute renal colic admitted to the hospital emergency department of Imam Khomeini's Sari accepts.For the study after obtaining necessary permits and after getting consent and explain to patients about the study, 196 patients with acute renal colic were randomly selected.Inclusion criteria:Clinical symptoms of renal colic with hematuria at least one of three in a urine analysis test, see stone radiography (Kidney Ureter Bladder = KUB) or ultrasound of the urinary Hungarian.Exclusion criteria:Heart disease, liver and kidney (except for kidney stones)
Insensitivity to buprenorphine.Previous seizure history.Using random allocation to two groups (98 patients) and control (n = 98) are divided.For patients with sublingual buprenorphine tablets manufactured by Faran chemistry as sublingual 2 mg intravenously at a rate of 5 ml with distilled water as a placebo will be administered.To control the amount of morphine 1.0 mg per kg body weight will be administered a sublingual placebo pills.The pain and nausea and vomiting before, and at intervals of 20, 40 and 60 minutes after intervention were assessed and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082023696N1
Registration date:2015-10-21, 1394/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Seyed Mohammad Hosseininejad
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3337 7169
Email address
mhoseininejad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical Science
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-10-30, 1394/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sublingual buprenorphine and acute kidney pain in patients with renal colic Hospital Emergency Department
Public title
The effect of sublingual buprenorphine and acute kidney pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical symptoms of renal colic with hematuria of at least one of the three tests on a urine analysis, x-ray view stone Or ultrasound of the Hungarian urine; Insensitivity to buprenorphine.
Exclusion criteria: Previous seizure history; Heart disease, liver and kidney (except for kidney stones);Drug addiction;See a history of frequent (more than 3 times a year) because of acute renal colic emergency department ;Pregnancy; Patients with fever (temperatures over 38 ° C);Hypersensitivity to opioid;The patient hemodynamically unstable (systolic blood pressure less than 90 mm Hg);Get pain medication at 6 hours prior to admission to the emergency department.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
196
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University Of Medical Science
Street address
Mazandaran, Sari
City
Sari
Postal code
Approval date
2015-08-31, 1394/06/09
Ethics committee reference number
1159.Code: IR.MAZUMS.REC.94
Health conditions studied
1
Description of health condition studied
acute renal colic pain
ICD-10 code
N23
ICD-10 code description
acute renal colic pain
Primary outcomes
1
Description
Renal colic pain
Timepoint
Half an hour and an hour after intervention
Method of measurement
Questionnaire and vAS
Secondary outcomes
empty
Intervention groups
1
Description
Individually prescribed two painkillers
Category
Treatment - Drugs
2
Description
For patients with sublingual buprenorphine tablets manufactured by Faran chemistry as sublingual 2 mg intravenously at a rate of 5 ml with distilled water as a placebo will be administered
Category
Treatment - Drugs
3
Description
To control the amount of morphine 1.0 mg per kg body weight will be administered a sublingual placebo pills
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Seyed Mohammad Hoseininejad
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University Of Medical Science
Full name of responsible person
Ahmad Ali Enayati
Street address
Mazandaran, Sari, Mazandaran University Of Medical Science
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University Of Medical Science
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
Mazandaran Univercity Of Medical Science
Full name of responsible person
Dr Abolhassan Samakosh
Position
Resident Emergency Medicine
Other areas of specialty/work
Street address
Vaviasr bolvar- Sari-Mazandaran
City
Sari
Postal code
Phone
+98 912 595 6112
Fax
Email
mhoseininejad@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Science
Full name of responsible person
Dr Seyed Mohammad Hoseininejad
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Babol-Mazandaran
City
Babol
Postal code
Phone
+98 912 595 6112
Fax
Email
mhoseininejad@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthopedics Research Center, Mazandaran University Of Science
Full name of responsible person
Samira Aghajani
Position
Other areas of specialty/work
Street address
Sari-Mazandaran
City
sari
Postal code
Phone
+98 911 957 3875
Fax
Email
orthopedics@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)