Objective: Compare the efficacy of metoclopramide and ondansetron in the treatment of nausea and vomiting in patients with renal colic.
Design and setting: a randomized, double-blind, clinical trial study, single center, clinical trial phase 3. In this study, 180 samples were selected and allocated into two intervention and control groups using block randomization method during 18 months.
Inclusion criteria: Renal colic patients with nausea and vomiting; ASA I or II; Age between 18 to 80 years old.
Exclusion criteria: Unstable hemodynamic; recent use of antiemetic drugs; allergy to Metoclopramide and Ondansetron.
Intervention: All patients received 5 mg Morphine intravenously (IV) and 30 mg ketorolac intramuscularly to reduce pain. Control group received 10 mg metoclopramide, single dose intravenously. Intervention group received 4 mg ondansetron, single dose intravenously.
Main outcome measures: 1) Nausea severity assessment at 0 and 30 minutes after the drug injection using visual analogue scale, 2) Number of vomiting episodes from 30 minutes before until 30 minutes after drug injection, 3) Vital signs check at 0 and 30 minutes after injection, 4) Need for excessive drug to reduce nausea and vomiting 30 minutes after injection g, 5) Adverse effects of drugs
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091023552N9
Registration date:2016-10-01, 1395/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-01, 1395/07/10
Registrant information
Name
Abolfazl Jokar
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 2134
Email address
dr.a.jokar@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2015-09-13, 1394/06/22
Expected recruitment end date
2016-08-12, 1395/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of metoclopramide and ondansetron in the treatment of nausea and vomiting in patients with Renal colic
Public title
Comparison of metoclopramide and ondansetron on nausea and vomiting in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Renal colic patients with nausea and vomiting; ASA I or II; age between 18 to 80 years old; Patients satisfaction on participation in the study.
Exclusion criteria: Systolic blood pressure lower than 90 mmHg; Unstable hemodynamic; Opium addiction; history of uncontrolled diseases (Parkinson, Restlessness syndrome, Epilepsy, GI bleeding, Pheochromocytoma); Recent use of CNS depressant drugs; Recent use of antiemetic drugs; allergy to the drugs used in this study
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the randomization was conducted with block randomization method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.ARAKMU.REC.1394.158
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
2
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea severity
Timepoint
0 and 30 minutes after injection
Method of measurement
visual analogue scale
2
Description
Number of vomiting
Timepoint
from 30 minutes before until 30 minute after injection
Method of measurement
questionnaire
Secondary outcomes
1
Description
blood pressure
Timepoint
0 and 30 minutes after injection
Method of measurement
sphygmomanometer
2
Description
Pulse rate
Timepoint
0 and 30 minutes after injection
Method of measurement
pulse rate in 1 minute
3
Description
Respiratory rate
Timepoint
0 and 30 minutes after injection
Method of measurement
Respiratory rate in 1 minute
4
Description
Body Tempreture
Timepoint
0 and 30 minutes after injection
Method of measurement
Thermometer
5
Description
Need to excessive drugs
Timepoint
30 minutes after injection
Method of measurement
Observation
Intervention groups
1
Description
Control: These patients receive 10 milligram metoclopramide(made in Osvah Pharmaceutical Company in Islamic Republic Of Iran) single dose, intravenously.
Category
Treatment - Drugs
2
Description
Intervention: These patients receive 4 milligram ondansetron(made in Shahredaru Pharmaceutical Company in Islamic Republic Of Iran) single dose, intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Abolfazl Jokar
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak,Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
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 Arak University of Medical Sciences