Compression the analgesic effect of metoclopramide and ondansetron in renal colic
Design
A randomized, blinded clinical trial with a parallel group design of 150 patients, enrolled in 3 groups.
Settings and conduct
Patients referred to emergency department of Shahid Sadoughi and Shahid Rahnemoon hospitals of Yazd.
Patients are blind about the type of treatment. In the normal control group, the saline is given as a placebo. The physician is also blind about the type of treatment and the coded drugs will be given to them.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of renal stone by sonography
Age between 18 to 55 years
Exclusion criteria:
Complicated renal stone such as pyelonephritis
Oral or intravenous drug administration in 6 hours before refer to hospital
Addiction
Pregnancy
Chronic renal or liver disease
Bilateral stone
Drug allergy
Intervention groups
The participants will be randomly divided into groups A, B and C. Group A were treated with 0.1 mg/kg intravenous morphine and 0.075 mg/kg ondansetron , group B were treated with intravenous morphine at the same dose and 0.15 mg/kg metoclopramide. In group C, patients will be treated with 0.1 mg/kg intravenous morphine plus 5 cc normal saline.
Main outcome variables
Analgesic effect of drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130107012050N3
Registration date:2020-06-01, 1399/03/12
Registration timing:retrospective
Last update:2020-06-01, 1399/03/12
Update count:0
Registration date
2020-06-01, 1399/03/12
Registrant information
Name
Mohamadali Jafari Nodushan
Name of organization / entity
Shahid Sadoughi University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1828 4313
Email address
malijafari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compression the analgesic effect of metoclopramide and ondansetron in renal colic
Public title
Compression the analgesic effect of metoclopramide and ondansetron
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of renal stone by sonography
Age between 18 to 55 years
Exclusion criteria:
Complicated renal stone such as pyelonephritis
Oral or intravenous drug administration in 6 hours before refer to hospital
Addiction
Pregnancy
Chronic renal or liver disease
Bilateral stone
Drug allergy
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided so that the researcher has no involvement in it using randomized blocks with block size 4 (using a table of random displacements). The type of treatment include morphine and ondasetrone, morphine and metoclopramide and morphine and normal saline is assigned by an out-of-study person according to a randomized list and according to the codes corresponding to each patient who enters the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blind about the type of treatment. In the normal control group, the saline is given as a placebo. The physician is also blind about the type of treatment and the coded drugs will be given to them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi of medical sciences
Street address
Bahonar square
City
Yazd
Province
Yazd
Postal code
8915896346
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.274
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Pain control
Timepoint
On arrival, 15 minutes, 30 minutes, 1 and 2 hours after drug administration
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Nausea control
Timepoint
On arrival, 15 minutes, 30 minutes, 1 and 2 hours after drug administration
Method of measurement
Observation
Intervention groups
1
Description
Intervention group 1: In this group 0.1 mg/kg intravenous morphine sulfate from Exir_Iran company and 0.075 mg/kg ondansetron from Tehran daru will be injected once.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group 0.1 mg/kg intravenous morphine sulfate from Exir_Iran company and 0.15 mg/kg metoclopramide from Tehran daru will be injected once.
Category
Treatment - Drugs
3
Description
Control group: In this group 0.1 mg/kg intravenous morphine sulfate from Exir_Iran company plus 5 cc normal saline will be injected once
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Street address
Shahid Sadoughi hospital -Ave Sina Blvd- Safaiye
City
Yazd
Province
Yazd
Postal code
8915896346
Phone
+98 35 5558 9274
Email
Malijafari@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Rahnemon hospital
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Street address
Shahid Rahnemon hospital- Farokhi Ave
City
Yazd
Province
Yazd
Postal code
8915896346
Phone
+98 35 2266 5000
Email
Malijafari@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Habib Nikokar
Street address
Bahonar square
City
Yazd
Province
Yazd
Postal code
8915896346
Phone
+98 35 3822 4000
Email
maligafari@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Sadoughi hospital
City
Yazd
Province
Yazd
Postal code
8915896346
Phone
+98 913 358 9274
Email
malijafari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shaid Sadoughi hospital
City
Yazd
Province
Yazd
Postal code
8915896346
Phone
+98 913 358 9274
Email
malijafari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shaid Sadoughi hospital
City
Yazd
Province
Yazd
Postal code
8915896346
Phone
+98 913 358 9274
Email
malijafari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available