The effect of Nitrous Oxide in comparison to Oxygen combined with Fentanyl on the staying time and pain reduction in renal colic patients at Emergency room
The aim of this study is to compare fentanyl+Entonox (nitrous oxide+O2) vs. fentanyl+oxygen,as an analgesics agents, in patients with acute renal colic.
this study is a randomized, double blinded, without placebo control and in phase 2 of clinical trial.
120 adult patients with acute renal colic, age above 18 and with stable hemodynamic presenting to emergency department will enroll. atients were excluded if they have a drug reaction.
At the beginning 50 µg fentanyl will infused for all of the patients. After that, patients divide into two group First group will receive mask of Entonox and second group mask of oxygen. Quantitative measurement of pain will perform by visual analogue scale (VAS), before and 3-, 5-, 10- and 30-minute after the intervention. If the pain were not relief after 30 minutes, 50 µg fentanyl were infused & severity of pain will be measured again . If the pain continued, Ketorolac and Ketamine will be used. Hospitalization duration and severity of pain at specified time will be compared between patients in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020512369N1
Registration date:2016-06-19, 1395/03/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Omid Ahmadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 3464
Email address
o_ahmadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nitrous Oxide in comparison to Oxygen combined with Fentanyl on the staying time and pain reduction in renal colic patients at Emergency room
Public title
The effect of Nitrous Oxide in comparison to Oxygen combined with Fentanyl on the staying time and pain reduction in renal colic patients at Emergency room
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were as follows:
Age>18 yr; Definite diagnosis of renal colic; Stable hemodynamic (PR=60-100، SBP>100، SPO2>90%،RR=8-22); lack of analgesics usage during last 24 hour; absence of these conditions in patients history: asthma, COPD, intestinal obstruction, hypertension, heart failure, history of previous surgery on kidney and urinary tract, peptic ulcer, GI bleeding, previous history of allergy to fentanyl or other analgesic agents, loss of consciousness, head or chest trauma, pneumocephalus, pneumothorax, drug abuse, abdominal tenderness, rebound tenderness or guarding, retard menstruation; Fill the Informed consent form
Patients were excluded if:
The patient hemodynamic becomes unstable during the process of hospitalization; Hypersensitivity reaction to analgesic drugs occurred; The diagnosis were changed during the further investigations
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Isfahan University of Medical Sciences
Street address
Hezar jirib street, Isfahan Uuniversity of Medical Science
City
Isfahan
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
395024
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
duration of hospitalization
Timepoint
at the end of the intervention
Method of measurement
minutes by timer
2
Description
severity of pain
Timepoint
before and 3-, 5-, 10- and 30-minute after the intervention
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
At the beginning 50 microgram (µg) fentanyl was infused for all of the patients.
First group was received mask of oxygen.
Patients were able to remove the mask if their pain was relief. If the pain was not relief after 30 minutes, 50 µg fentanyl was infused again. Finally, if the patient was still suffering from pain, another usual pain relieving agent such as Ketorolac and Ketamine was used to decrease the severity of patient's pain.
Category
Treatment - Drugs
2
Description
At the beginning 50 microgram (µg) fentanyl was infused for all of the patients.
First group was received mask of oxygen.
Patients were able to remove the mask if their pain was relief. If the pain was not relief after 30 minutes, 50 µg fentanyl was infused again. Finally, if the patient was still suffering from pain, another usual pain relieving agent such as Ketorolac and Ketamine was used to decrease the severity of patient's pain.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr Omid Ahmadi
Street address
Alzahra hosital, Sofeh street, Isfahan, Iran
City
Isfahan
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciencesو Hezarjirib st, Isfahan, Iran
City
Isfahan
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, Isfahan 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
Department of Emergency Medicine, Isfahan University of Medical Sciences
Full name of responsible person
Omid Ahmadi
Position
Emergency Medicine specialist
Other areas of specialty/work
Street address
Department of Emergency Medicine, Alzahra hospital, Sofeh street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3261 3464
Fax
Email
omid.ep@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Emergency Medicine, Isfahan University of Medical Sciences
Full name of responsible person
Omid Ahmadi
Position
Emergency Medicine specialist
Other areas of specialty/work
Street address
Department of Emergency Medicine, Alzahra hospital, Sofe street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
omid.ep@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)