Protocol summary

Summary
The aim of this randomized controlled clinical trial is to compare the efficacy of intramuscular morphine and morphine suppository in relieving pain of patients with renal colic. The study will be done on 18 to 55 years old patients with renal colic who will come to the emergency department of Kowsar hospital in Semnan, Iran. Patients with unilateral acute flank or abdominal colicky pain will be included in the study that in evaluation of the patient with ultrasonography, CT scan or intravenous pyelography presence of the urinary stone will be approved or the patient will pass the stone. Exclusion criteria will be sensitivity to morphine, addiction, existence of fever, impaired hepatic or renal function, heart or respiratory failure, suspected to peritonitis, pregnancy and receiving analgesic within 6 hours before admission. Sample size will be 84 patients that will be divided with randomized permuted blocks into two groups (42 in each group). For control of pain one group will receive 10 mg intramuscular morphine and the other group 10 mg morphine suppository. First, the intensity of patient pain will be assessed based on VAS (visual analogue scale) and after control of blood pressure, pulse and respiratory rate and recording them in the questionnaire, they will be treated with morphine suppository or intramuscular morphine. In 15, 30 and 60 minutes intervals after drug prescription, reevaluation according to pain relief based on VAS as well as morphine side effects will be done. Demographic data, VAS points and drug side effects will be recorded in the questionnaire.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015111825098N1
Registration date: 2016-03-18, 1394/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-18, 1394/12/28
Registrant information
Name
Arash Ardestani Zadeh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7830
Email address
arardestani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
university
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the analgesic efficacy of intramuscular morphine and morphine suppository in patients with renal colic
Public title
Comparison the analgesic efficacy of intramuscular morphine and morphine suppository in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-55 years old patients with unilateral acute flank or abdominal colicky pain that in evaluation of the patient with ultrasonography, CT scan or intravenous pyelography presence of the urinary stone is approved or the patient passes the stone. Exclusion criteria : sensitivity to morphine; addiction; fever higher than 38 degrees of centigrade; unstable hemodynamic condition; impaired hepatic or renal function; heart failure; respiratory failure; suspected to peritonitis; pregnancy or suspected to pregnancy; transplanted kidney; suspected to aneurysm or dissection of aorta and receiving analgesic within 6 hours before admission.
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: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Central building of the university, Basij Blvd., Semnan
City
Semnan
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR SEMUMS.REC.1394.129

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 intensity
Timepoint
Before intervention, 15, 30 and 60 minutes after intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before intervention, 15, 30 and 60 minutes after intervention
Method of measurement
Sphygmomanometer

2

Description
Heart rate
Timepoint
Before intervention, 15, 30 and 60 minutes after intervention
Method of measurement
Counting the number of radial pulse

3

Description
Respiratory rate
Timepoint
Before intervention, 15, 30 and 60 minutes after intervention
Method of measurement
Counting the number of breaths

4

Description
Nausea and Vomiting
Timepoint
Before intervention, 15, 30 and 60 minutes after intervention
Method of measurement
Question of the patient and observation

5

Description
Dizziness
Timepoint
15, 30 and 60 minutes after intervention
Method of measurement
Question of the patient

6

Description
Drowsiness
Timepoint
15, 30 and 60 minutes after intervention
Method of measurement
Observation

7

Description
Facial Flushing
Timepoint
15, 30 and 60 minutes after intervention
Method of measurement
Observation

8

Description
Size of urinary stone
Timepoint
After intervention
Method of measurement
Imaging findings

9

Description
Location of the stone
Timepoint
After intervention
Method of measurement
Imaging findings

Intervention groups

1

Description
Intervention group: Patients with renal colic that receive 10 mg intramuscular Morphine Sulfate (manufactured by Darou Pakhsh Pharmaceutical Co.) for control of pain
Category
Treatment - Drugs

2

Description
Control group: Patients with renal colic that receive 10 mg suppository of Morphine Sulfate (brand name: Opirect, manufactured by Aburaihan Pharmaceutical Co.) for control of pain
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Dr Arash Ardestani Zadeh
Street address
Kowsar hospital, Basij Blvd., Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidypour
Street address
Central building of university, Basij Blvd., Semnan
City
Semnan
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 of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Arash Ardestani Zadeh
Position
Fellowship of Endourology
Other areas of specialty/work
Street address
Kowsar hospital, Basij Blvd., Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
ardestani_a@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Arash Ardestani Zadeh
Position
Fellowship of Endourology
Other areas of specialty/work
Street address
Kowsar hospital, Basij Blvd., Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
ardestani_a@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Arash Ardestani Zadeh
Position
Fellowship of Endourology
Other areas of specialty/work
Street address
Kowsar hospital, Basij Blvd., Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
ardestani_a@yahoo.com
Web page address

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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