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Comparison of the analgesic effect of intravenous metoclopramide and morphine in the treatment of acute renal colic, A randomized double-blind trial

Protocol summary

Study aim
Comparison of the analgesic effect of intravenous metoclopramide and morphine in the treatment of acute renal colic
Design
Clinical trial with intervention and control group, with parallel groups, double-blind, randomized using block method, phase three on 68 patients
Settings and conduct
In this study, patients between 18-55 years old who have inclusion criteria are included in the study. Patients are chosen in the emergency room of Golestan hospital in Ahvaz, 17 Shahrivar and Shahid Beheshti hospital in Abadan. Based on the patient's complaint, patient's history, physical examination, and medical records, patients with renal colic have been diagnosed. Patients sign a consent form and then enter the study. The study process is double-blind and the participants, researchers and staff are blinded and treatment protocol are named A and B, are chosen randomly by lottery under researcher and second nurse supervision, patients are divided into two groups of intervention and control groups as permuted block.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients between ages of 18 and 55 who have been diagnosed with renal colic. Exclusion criteria: All patients aged under 18 years and over 55 years; All patients allergic to morphine and metoclopramide All patients who do not want to cooperate for any reason; All patients who do not fill out the consent form; Pregnant patients. Patients with fever over 38 degrees Patients with unstable hemodynamics Patients with heart, kidney, lung and liver defect Use any sedative up to 24 hours before going to the emergency room
Intervention groups
Control group: In control group, pain intensity is evaluated by visual analogue scale and morphine 0.1 mg/kg with 100 cc normal saline is injected. Intervention group: In the intervention group, intravenous metoclopramide (10mg) is injected.
Main outcome variables
Reduce pain intensity and pain control speed

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200505047304N1
Registration date: 2020-10-05, 1399/07/14
Registration timing: retrospective

Last update: 2020-10-05, 1399/07/14
Update count: 0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Taghva Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5335 0950
Email address
taghvafathi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of intravenous metoclopramide and morphine in the treatment of acute renal colic, A randomized double-blind trial
Public title
Effect of Metoclopramide on Kidney Stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged between 18 and 55 years who have been diagnosed with renal colic
Exclusion criteria:
Patients under 18 years and over 55 years old Patients who are allergic to morphine and metoclopramide Patients who do not want to cooperate after the start of research for any reason (e.g. due to drug complications) Patients who do not fill out the consent form Pregnant Women Patients with a Fever over 38 degrees Unstable hemodynamics Heart, kidney, lung or liver defects Use of any sedative up to 24 hours before going to the emergency room.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
randomization will be done using the site https://www.sealedenvelope.com/ in two groups A and B in six-digit blocks. This list will be provided to the relevant doctor after printing.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and data analyzers will not be informed of the type of drug (A or B) until the end of the study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Science., Esfand Ave., Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.AJUMS.REC.1398.903

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
Average pain score on visual analogue scale
Timepoint
Measuring the average pain score at the beginning of the study (before starting the intervention) and 15, 30, 45 and 60 minutes after the intervention begins
Method of measurement
VAS (Visual Analogue Scale)

Secondary outcomes

empty

Intervention groups

1

Description
control group: In the control group, the severity of pain is first evaluated by Visual Analogue Scale (VAS) criteria and the morphine 0.1 mg / kg is injected with 100cc normal saline and the severity of pain based on VAS is evaluated in zero, 15, 30, 45 and 60 minutes. And if in the 30th minute, the patient's pain criterion is based on VAS is more than 5, morphine is injected again for the patient, and if at the end of 60 minutes, the patient's pain is less than 2, the patient is discharged without additional work.
Category
Treatment - Drugs

2

Description
Using visual analog scale, they are assessed for pain intensity after drug injection (worst possible pain = 10 without pain = 0). Patients receive intravenous metoclopramide intervention at a dose of 10 mg. In the 15th minute, the pain is assessed with VAS, which is considered to be significant for greater than or equal to 2. In the 30th minute from the start of treatment, if the pain is more than 5 with VAS,The patient's pain is controlled with morphine. In the 45th and 60th minutes, the patient's pain is examined according to the VAS criteria. If the patient's pain is less than 2 in the 60th minute based on VAS, the patient is discharged from the emergency room without any additional action.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital of Ahvaz
Full name of responsible person
Farshad Fathi
Street address
Farvardin Blvd, Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6318911151
Phone
+98 61 3374 3001
Email
golestanhospital@yahoo.com

2

Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Farshad Fathi
Street address
End of Khalij Fars Blvd, Shotait District
City
Abadan
Province
Khouzestan
Postal code
6318911151
Phone
+98 61 5335 4546
Email
abadan.hospital@yahoo.com

3

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Farshad Fahi
Street address
Ahmad Abad Ave
City
Abadan
Province
Khouzestan
Postal code
6316648371
Phone
+98 61 5332 3094
Email
hospital.beheshti.abadan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badoui
Street address
Ahvaz Jundishapur University of Medical Science., Esfand Ave., Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Dr.MohammadBedoui@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Taghva Fathi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 18 , 17 shahrivar hospital
City
Abadan
Province
Khouzestan
Postal code
6318911151
Phone
+98 61 5335 0950
Email
taghvafathi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Ganji
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy., Ahvaz Jundishapur University of Medical Science., Esfand Ave., Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098 61 3311
Email
rg.pharm777@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Taghva Fathi
Position
ُStudent
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 18 , 17 Shahrivar Hospital
City
Abadan
Province
Khouzestan
Postal code
6318911151
Phone
+98 61 5335 0950
Email
Taghvafathi@gmail.com

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
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