Objective: Comparison the effect of intravenous magnesium sulfate and intravenous ketorolac on pain of patients with renal colic
Design: Parallel single blind randomized clinical trial
Randomization: Patients will allocate to two equal groups according to table of random numbers.
Participants including major eligibility criteria: This study will conduct on 84 patients with renal colic affiliated to acute emergency department of Ahvaz Golestan hospital. Main inclusion criteria include diagnosis of renal colic with sonography; age of 18-55 years; having pain score of 5 based on visual analog score in admission time and main exclusion criteria include having history of heart, liver, kidney, metabolic diseases and seizures; systolic blood pressure below 90 mmHg; fever more than 37 degrees Celsius; pregnancy; abdominal pain and probable peritonitis; using calcium channel blockers.
Main outcome: Pain severity
Intervention: Patients in first group will receive ketorolac via intravenous with dosage of 30 mg in combination to 100 cc intravenous normal saline during 15 minutes. Patients in second group will receive 50 mg per kilogram intravenous magnesium sulfate 50% with total dosage of 100 cc during 15 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050125027N2
Registration date:2016-12-21, 1395/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Mohammadreza Maleki Varaki
Name of organization / entity
Ahvaz Judishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
maleki-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intravenous magnesium sulfate and intravenous ketorolac on pain of patients with renal colic
Public title
Comparison the effect of intravenous magnesium sulfate and intravenous ketorolac on pain of patients with renal colic affiliated to acute emergency department of Ahvaz Golestan hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of renal colic with sonography; age of 18-55 years; having pain score of 5 based on visual analog score in admission time.
Exclusion criteria: history of heart, liver, kidney, metabolic diseases and seizures; systolic blood pressure below 90 mmHg; fever more than 37 degrees Celsius; pregnancy; abdominal pain and probable peritonitis; using calcium channel blockers.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.AJUMS.REC.1395.458
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
In 15, 30, 45 and 60 minutes after intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Pulse rate
Timepoint
In 15, 30, 45 and 60 minutes after intervention
Method of measurement
Researcher-made questionnaire
2
Description
Blood pressure rate
Timepoint
In 15, 30, 45 and 60 minutes after intervention
Method of measurement
Researcher-made questionnaire
3
Description
Atrial oxygen saturation
Timepoint
In 15, 30, 45 and 60 minutes after intervention
Method of measurement
Researcher-made questionnaire
4
Description
Respiratory rate
Timepoint
In 15, 30, 45 and 60 minutes after intervention
Method of measurement
Researcher-made questionnaire
5
Description
Nausea and vomiting
Timepoint
In 15, 30, 45 and 60 minutes after intervention
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
Patients in first group will receive ketorolac via intravenous with dosage of 30 mg in combination to 100 cc intravenous normal saline during 15 minutes
Category
Treatment - Drugs
2
Description
Patients in second group will receive 50 mg per kilogram intravenous magnesium sulfate 50% with total dosage of 100 cc during 15 minutes.