Comparative study of drug combination (morphine-granisetron) with (morphine-placebo) in patients with kidney stones for the control of pain and nausea and vomiting
Comparative study of drug combination (morphine-granisetron) with (morphine-placebo) in patients with kidney stones for the control of pain and nausea and vomiting
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 60.
Settings and conduct
In this research, all patients referred to the Emergency Department of Hazrat Rasoul Akram Hospital, who suffered from renal colic will be enrolled. Patients will be randomly divided into two groups based on 10 blocks. A total of 120 patients will be examined. Patients and data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Hazrat Rasoul Akram Hospital, who suffered from renal colic will be enrolled. Inclusion criteria: age over 16 years old; emergency medicine specialist diagnoses renal colic; no history of allergy to granisetron if mentioned by the patient or a partner; possibility of getting IV Line. Exclusion criteria: patients under the 16 years old; patient unwillingness to continue treatment and follow-up.
Intervention groups
In intervention group: 0.1 mg / kg morphine sulfate intravenously, simultaneously, patients will receive a 5 cc syringe containing 40 mg / kg of intravenous granisetron.
In control group 0.1 mg / kg morphine sulfate intravenously, at the same time patients will receive a 5 cc syringe containing saline.
Main outcome variables
Severity of pain; severity of nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170105031787N4
Registration date:2019-08-18, 1398/05/27
Registration timing:prospective
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Mohammad-Reza Yasinzadeh
Name of organization / entity
Iran university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
yasinzadeh.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-16, 1398/06/25
Expected recruitment end date
2019-12-16, 1398/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of drug combination (morphine-granisetron) with (morphine-placebo) in patients with kidney stones for the control of pain and nausea and vomiting
Public title
Evaluation of drugs combination in patients with kidney stones
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Emergency medicine specialist diagnoses renal colic
No history of allergy to granisetron if mentioned by the patient or a partner
Possibility of getting IV Line
Exclusion criteria:
Patient unwillingness to continue treatment and follow-up
Age under 16 years
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 12 blocks will be considered for sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data will be analyzed by person who is blind to study groups, and patients will also be unaware of the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat highway, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1397.1191
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
Severity of pain
Timepoint
At the beginning of the injection, half an hour and one hour after the injection
Method of measurement
Visual Analogue Score
2
Description
Severity of nausea
Timepoint
At the beginning of the injection, half an hour and one hour after the injection
Method of measurement
Based on the patient's statement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.1 mg / kg morphine sulfate intravenously, Simultaneously, Patients will receive a 5 cc syringe containing 40 mg / kg of intravenous granisetron
Category
Treatment - Drugs
2
Description
Control group: 0.1 mg / kg morphine sulfate intravenously, at the same time patients will receive a 5 cc syringe containing saline.