The purpose of this study is to compare the effects of morphine and Ketofol in the treatment of patients with severe urolithiasis pain that unresponsive to IV ketorolac All patients with severe refractory to intravenous Ketorolac pain will be enrolled in this study. Patients with addiction to opioid drugs, allergy to egg and allergy to morphine will be excluded. The sample size is considered 120 patients. Patients will be divided to intervention group, treated with IV Ketofol, and the control group, treated with IV morphine.Severity of pain is measured based on the numerical pain score. At control group patient’s 0.1 mg/kg intravenous morphine will be injected and then after 5 and 10 minute the Severity of pain numerically will be measured and will be documented. At intervention group patient’s 0.75 mg/kg propofol plus 0.75 mg/kg ketamine intravenous will be injected and then after 5 and 10 minute the Severity of pain numerically will be measured and will be documented. Both groups will be compared in terms of pain relief.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052417812N1
Registration date:2014-07-17, 1393/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-17, 1393/04/26
Registrant information
Name
Gholamreza Faridaalaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 9540
Email address
faridaalaee@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia Medical University of Medical Siences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Intravenous Morphine and Ketofol in treatment of severe acute pain of urolitiasis resistant to ketorolac
Public title
comparison between morphine and ketofol in renal colic patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: all patients with severe acute pain who are resistant to IV ketorolac.
exclusion criteria: allergy to morphine; allergy to egg; patients with addiction to opium; hemodynamic instability.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Urmia University of Medical Scinces
Street address
Urmia University of Medical Scinces; ResalatAvenue
City
Urmia
Postal code
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
umsu.rec.1393.66
Health conditions studied
1
Description of health condition studied
Urolithiasisi
ICD-10 code
N 20
ICD-10 code description
Calculus of kidney
2
Description of health condition studied
Urolithiasisi
ICD-10 code
N 21
ICD-10 code description
Calculus of lower urinary tract
3
Description of health condition studied
Urolithiasisi
ICD-10 code
N 22
ICD-10 code description
Calculus of urinary tract in diseases classified elsewhere
4
Description of health condition studied
Urolithiasisi
ICD-10 code
N 23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain relief
Timepoint
Q 5 minute up to 15 minute
Method of measurement
10 numerical score with Visaul Analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In control group 0.1 mg / kg / IV morphine will be injected.
Category
Treatment - Drugs
2
Description
intervention group, 0.75 mg / kg IV ketamine + 0.75 mg / kg /IV propofol will be injected.