Protocol summary

Summary
Objective: Since the higher quality of pain control with less complication is always an important issue in emergency departments, this study aims to compare the effects and complications of narcotic and narcotic in addition to naloxone. Design: A double-blind randomized clinical trial in which randomization will be performed using the random number table. Inclusion criteria: Renal colic and pain score of 7-10 based on VAS. The exclusion criteria are pregnancy, sensitivity to the drugs used in the study, morphine contraindications, history of drug dependence, receiving a calmative drug during 6 hours before the visit, peritoneal symptoms in abdominal examination, history of cardiovascular diseases, psychosis and patient withdrawal to participate in the study, acute ischemic disease, age above 60, absence of renal colic in further studies. Sample size: 280 subjects. Intervention: A group of patients with renal colic will receive morphine (0.1 mg / kg) and placebo through a double-blind random method and the other group will receive the same dose of morphine with naloxone (0.001 mg/kg). An additional dose of 0.05 mg/kg morphine will be given to both groups after twenty minutes if needed (no pain control). Duration of intervention: From the beginning of admission to the emergency department. Primary outcomes: Pain, nausea, sedation, number of breaths, and blood pressure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031923696N5
Registration date: 2017-08-17, 1396/05/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-17, 1396/05/26
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
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effects and complications of morphine plus very low dose of naloxone with morphine alone on renal colic patients
Public title
Comparing the effect of morphine with combined morphine and naloxone on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: renal colic; the severity of pain according to VAS should be 7 to10. Exclusion criteria: pregnancy; allergies to medications used in the study; morphine contraindications; addicted to drugs; get analgesic in 6 hours prior to the study; the presence of symptoms of peritoneal in abdominal examination; history of cardiovascular disease; psychosis; unwillingness to participate in the study; acute ischemic disease; age over 60 years.
Age
From 84 years old to 34 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the randomization of random number table was used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem Square, Sari, Iran
City
Sari
Postal code
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITA.REC95.2627

Health conditions studied

1

Description of health condition studied
renal colic
ICD-10 code
n20,n21,n2
ICD-10 code description
Calculus of kidney,Calculus of lower urinary tract,Calculus of urinary tract in diseases classified elsewhere,Unspecified renal colic

Primary outcomes

1

Description
Pain
Timepoint
At the beginning of the intervention, 20, 40, 60, 120, 180 min after intervention
Method of measurement
VAS Scoring (visual analogue scale)

Secondary outcomes

1

Description
Blood pressure
Timepoint
0,20,40,60,120 and 180 min after intervention
Method of measurement
Mercury Sphygmomanometer

2

Description
Sedation
Timepoint
0,20,40,60,120 and 180 min after intervention
Method of measurement
Ramsay sedation scale

3

Description
Nausea
Timepoint
0,20,40,60,120 and 180 min after intervention
Method of measurement
VAS (visual analogue scale)

Intervention groups

1

Description
Intervention group: Morphine, manufactured by Dr Abidi Laboratory, 0.1 mg/kg intravenous injection, at min 0 and min 20, and Naloxone, manufactured by Dr Abidi Laboratory, 0.001 mg/kg intravenous injection, single dose, at min 0.
Category
Treatment - Drugs

2

Description
Intervention group: Morphine, manufactured by Dr Abidi Laboratory, 0.1 mg/kg intravenous injection, at min 0 and min 20, and distilled water, manufactured by Dr Abidi Laboratory, 5 ml, intravenous injection, single dose, at min 0.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini hospital of Sari
Full name of responsible person
Mehdi Muhammadianamiri
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
University of Medical Sciences, Valiasr Highway, Juibar Crossroad, Imam Square, Sari, Iran
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Muhammadian Amiri
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Postal code
Phone
+98 11 3335 5980
Fax
Email
Mhoseininejad@mazums.ac.ir; dr_muhammadian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hoseininejad
Position
Emergency Medicine Spicialist
Other areas of specialty/work
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Postal code
Phone
+98 113330550
Fax
Email
Mhoseininejad@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Muhammadian Amiri
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Postal code
Phone
+98 113330550
Fax
Email
bnf.nr70@gmail.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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