1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Efficacy and Safety of Combination Therapy with Ketorolac and Morphine in Patient with Acute Renal Colic; A Triple-Blind Randomized Controlled Clinical Trial
Protocol summary
Summary
(1) Objectives: The aim of the current study is to compare the efficacy and safety of combined therapy with morphine and ketorolac and monotherapy with each drug alone in patients with acute renal colic. (2) Design:
Randomized, triple-blind, placebo-controlled clinical trial.
(3) Setting and conduct: Tertiary general health care center (4) Participants including major eligibility criteria:
A total number of 300 adult patients (18-55 years) with acute renal colic with pain score of more than 5 measured by visual analogue scale (VAS). (5)
Intervention: All the patients will randomly be assigned to received 30mg intravenous ketorolac and 0.1mg/kg morphine (n=100) or intravenous 0.1mg/kg morphine and placebo (n=100) or intravenous 30 mg ketorolac (n=100). (6) Main outcome measures (variables): The pain scores measured by VAS would be recorded at baseline, 20-min and 40-min after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT201706032445N6 Registration date: 2017-06-07, 1396/03/17 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2017-06-07, 1396/03/17 Registrant information
Name
Fariborz Ghaffarpasand Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of) Phone
+98 71 3647 4259 Email address
ghafarf@sums.ac.ir Recruitment status
Recruitment complete Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date 2014-03-01, 1392/12/10
Expected recruitment end date 2014-09-01, 1393/06/10 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Efficacy and Safety of Combination Therapy with
Ketorolac and Morphine in Patient with Acute Renal Colic;
A Triple-Blind Randomized Controlled Clinical Trial Public title
Ketorolac and Morphine for Renal Colic Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-55 years; Clinical diagnosis of acute renal colic (sudden sharp colic flank pain with or without radiation to genitalia or groin and with or without urinary symptoms); Pain score of 5 or more measured by 10-cm visual analogue scale (VAS). Exclusion criteria:
history of kidney or renal dysfunction and severe
2 dehydration; pregnancy; breastfeeding; single kidney or
kidney transplantation; history of peptic ulcers and gastrointestinal bleeding; receiving analgesics within 6 hours before presentation; history of bleeding diathesis;
history of cardiovascular disease and the use of angiotensin-converting-enzyme inhibitor (ACE inhibitor) or angiotensin receptor blockers (ARB); anticoagulant medication or coagulation disorders; history of drug dependence or current use of methadone or chronic consumption of tobacco and alcohol; peritonitis;
presence of any peritoneal sign.
Age
From 18 years old to 55 years old Gender
Both Phase
2
Groups that have been masked No information
Sample size
Target sample size: 300
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Triple blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences Street address
Mazandaran University of Medical Sciences, Vali Asr Avenue, Emam Square
City Sari Postal code Approval date
2015-05-06, 1394/02/16
Ethics committee reference number IR.MAZUMS.REC.94.858
Health conditions studied
1
Description of health condition studied Acute Renal Colic
ICD-10 code N23
ICD-10 code description Unspecified renal colic
Primary outcomes
1
Description Pain Timepoint
0, 20 and 40 minutes Method of measurement
Visual analogue scale
Secondary outcomes
1
Description Adverse effects Timepoint
0, 20 and 40 minutes Method of measurement
Clinical examination
Intervention groups
1
Description
30mg Intravenous Ketorolac + 0.1 mg/kg Intravenous Morphine Sulphate
Category
Treatment - Drugs
2
Description
0.1 mg/kg Intravenous Morphine Sulphate Category
Treatment - Drugs
3
Description
30mg Intravenous Ketorolac Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center Emam Khomeini Hospital Full name of responsible person
Mehran Amooei Khanabbasi Street address
3 City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person Ahmad Ali Enayati
Street address
Faculty of Public Health, KM 18 Kazarabad Road, The Campus of Mazandaran University of Medical Sciences
City Sari 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 Mazandaran University of Medical Sciences
Proportion provided by this source 100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences Full name of responsible person
Mehran Amooei Khanabbasi Position
MD
Other areas of specialty/work Street address
Mazandaran University of Medical Sciences, Vali Asr Avenue, Emam Sqaure
City Sari Postal code Phone
+98 921 670 7983 Fax
farzadbozorgi1356@gmail.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandran University of Medical Sciences Full name of responsible person
Mehran Amooei Khanabbasi Position
MD
Other areas of specialty/work Street address
Mazandran University of Medical Sciences, Vali Asr Avenue, Emam Square
City Sari Postal code Phone
+98 921 670 7983 Fax
farzadbozorgi1356@gmail.com Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandran University of Medical Sciences Full name of responsible person
Mehran Amooei Khanabbasi Position
MD
Other areas of specialty/work Street address
Mazandran University of Medical Sciences, Vali Asr Avenue, Emam Square
City Sari Postal code Phone
+98 921 670 7983 Fax
farzadbozorgi1356@gmail.com Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
4 empty
