Suppository morphine versus intravenous morphine in controlling pain of patients with impression of renal colic referred to Rasoul-Akram hospital emergency department since October 23rd 2010 to March 21st 2011
This study is conducted to evaluate efficacy of suppository morphine versus intravenous (IV) morphine in controlling pain of patients who referred to Rasoul-Akram hospital emergency department with impression of renal colic. Those patients between 16 and 60 years old were enrolled and those with any contraindication to morphine usage were excluded.
They were randomized in 2 groups, suppository morphine and IV placebo and Suppository placebo and IV morphine. Pain scores would be recorded 0, 30, 60 minutes after intervention. All possible side effects also will record.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106076739N1
Registration date:2012-02-01, 1390/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Fatemeh Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00892144516738
Email address
fa-mohammadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Suppository morphine versus intravenous morphine in controlling pain of patients with impression of renal colic referred to Rasoul-Akram hospital emergency department since October 23rd 2010 to March 21st 2011
Public title
morphine suppository in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with impression of renal colic; 16 - 50 years old
Exclusion criteria: known allergy to morphine or intolerance; presence of significant anorectal pathology; concurrent use of other opioides
Age
From 16 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
16 azar st, tehran
City
Tehran
Postal code
Approval date
2010-11-06, 1389/08/15
Ethics committee reference number
1/897
Health conditions studied
1
Description of health condition studied
renal colic
ICD-10 code
N23
ICD-10 code description
unspecified renal colic
Primary outcomes
1
Description
PAIN AFTER TREATMENT
Timepoint
30 and 60 min later
Method of measurement
numerical rating scale
Secondary outcomes
1
Description
adverse effectes of morphine suppository
Timepoint
30 and 60 min later
Method of measurement
questioner, (present/absent)
Intervention groups
1
Description
In one group patients were recieved one morphine suppository and 5 cc freewater
Category
Treatment - Drugs
2
Description
In another group patients were recieved 5 mg IV morphine and one placebo suppository
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rsoul-e-Akram Hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Sattrakhan, niyayesh
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
deputy of research
Street address
16 Azar st
City
Tehran
Grant name
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran univeraity of medical sciences
Full name of responsible person
Dr fateme mohammadi
Position
emergency medicine resident
Other areas of specialty/work
Street address
Rasul-e- Akram hosphtal
City
Tehran
Postal code
14456
Phone
+98 21 4451 6738
Fax
Email
dr.fmohammadi304@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Mohammad Amin Zare
Position
Faculty of medicine, emergency medicine department
Other areas of specialty/work
Street address
Hazrat Rasul Akram hospital
City
Tehran
Postal code
14456
Phone
+98 982164352222
Fax
Email
mazare74@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Saeed Abbasi
Position
Faculty in medicine, Emergency Medicine Department
Other areas of specialty/work
Street address
Rasoul-e-Akram Hospital, Niayesh, Sattarkhan
City
Tehran
Postal code
14456
Phone
+98 66518098
Fax
+98 66525327
Email
saieedabbasi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)