Protocol summary

Summary
In this double blind study, we will select two groups of 150 renal colic patients; with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively; according to Balanced Block Randomization method and inclusion and exclusion criteria. Inclusion criteria include : age 18-69 years old Pain score equal or more than 40 or 4 in VAS or NRS system, respectively; and Exclusion criteria include: Pyelonephritis or fever equal or more than 38 degree centigrade, History of addiction or opioid allergy, History of cardiovascular disease (function class 3-4 or decompensated CHF or uncontrolled hypertension) , History of active hepatobiliary disorders Hemodinamically unstable patients (BP below 90mmHg or MAP decreased more than 30% baseline), Pregnancy and Breast feeding and History of CVA in last 2 years. Group A will receive 1 cc saline as placebo and group B will receive 1 CC of low dose naloxone (0.04 mg) intravenously. 5 minutes later, both groups will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue. During this study, we will assess if naloxone could diminish the pain score and total dose of morphine administration in according to lower complications than morphine and placebo in renal colic patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106146804N1
Registration date: 2011-12-17, 1390/09/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-17, 1390/09/26
Registrant information
Name
Mohammad Javad Behzadnia
Name of organization / entity
Baghyatallah medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2012
Email address
behzadnia@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research , Baghyatallah Medical Sciences University.
Expected recruitment start date
2011-12-10, 1390/09/19
Expected recruitment end date
2012-04-07, 1391/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of analgesic and complications of intravenous morphine and placebo with intravenous naloxon and morphine in renal colic patients
Public title
Assessment of efficacy and complication of morphine and naloxan in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include : age 18-69 years old; Pain score equal or more than 40 or 4 in VAS or NRS system, respectively; and Exclusion criteria include: Pyelonephritis or fever equal or more than 38 degree centigrade; History of addiction or opioid allergy;History of cardiovascular disease (function class 3-4 or decompensated CHF or uncontrolled hypertension) ; History of active hepatobiliary disorders ; Hemodinamically unstable patients (BP below 90mmHg or MAP decreased more than 30% baseline) ;Pregnancy and Breast feeding and History of CVA in last 2 years.
Age
From 18 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 300
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
Baghyatallah medical sciences university ethics committee
Street address
3rd floor, Central department, Baghyatallah Medical Sciences University, Vice Chancellor for research, Nosrati alley, Sheikh Bahaie Molla St, Sadra St, Vanaq sq, Tehran, Iran
City
Tehran
Postal code
1435916471
Approval date
2011-12-01, 1390/09/10
Ethics committee reference number
6702-بند 17

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 severity
Timepoint
Every 15 min during 90 min
Method of measurement
Questionaire,according to VAS or NRS pain score systems

Secondary outcomes

1

Description
Side effects
Timepoint
Every 15 min during 90 min
Method of measurement
Questionaire,according to physical examination and patients observation

Intervention groups

1

Description
150 renal colic patients in group B (intervention group), with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively, will receive 1 CC of low dose naloxone (0.04 mg) intravenously in similar syringes. 5 minutes later,this group will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue.
Category
Treatment - Drugs

2

Description
150 renal colic patients in Group A (control group); with 18-69 years old age and Pain score, equal or more than 40 or 4 in VAS or NRS system, respectively, will receive 1 cc saline as placebo intravenously. 5 minutes later,this group will receive 2.5 mg morphine sulfate intravenously. Then we will fallow the patients according to their pain score and complications every 15 minutes for about 90 min. If the pain score does not diminish below 4, we will administer other doses of morphine (max dose: 10 milligram). If despite the Morphine administration (max dose: 10 mg), pain score remains more than the mentioned threshold, the patient will exclude from the study but his pain management will continue.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghyatallah hospital
Full name of responsible person
Dr Mohammad Javad Behzadnia
Street address
Emergency department, Baghyatallah Hospital, Nosrati alley, Sheikh Bahaie Molla St, Sadra St, Vanaq sq.,Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research , Baghyatallah Medical Sciences University.
Full name of responsible person
Dr Gholamhosein Alishiri
Street address
3rd floor, Central department, Vice Chancellor for research , Baghyatallah Medical Sciences University, Nosrati Alley, Sheikh Bahaie Molla St, Sadra St, Vanaq sq., Tehran, Iran
City
Tehran
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 , Baghyatallah Medical Sciences University.
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
Baghyatallah Medical Sciences University
Full name of responsible person
Dr Mohammad Javad Behzadnia
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Emergency department, Baghyatallah Hospital, Nosrati Alley, Sheikh Bahaie St, Molla Sadra St, Vanaq sq., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2277 4528
Fax
Email
Behzadnia@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baghyatallah medical sciences university
Full name of responsible person
Dr Mohammad Javad Behzadnia
Position
emergency medicine resident
Other areas of specialty/work
Street address
Emergency department, Baghyatallah Hospital, Nosrati Alley, Sheikh Bahaie St, Molla Sadra St, Vanaq sq., Tehran, Iran .
City
Tehran
Postal code
Phone
+98 21 2277 4528
Fax
Email
behzadnia@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baghyatallah medical sciences university
Full name of responsible person
Dr Mohammad Javad Behzadnia
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Emergency department, Baghyatallah Hospital, Nosrati Alley, Sheikh Bahaie St, Molla Sadra St, Vanaq sq.,Tehran, Iran.
City
Tehran
Postal code
Phone
Fax
Email
behzadnia@bmsu.ac.ir
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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