Determination of the proper method for creating an appropriate local anesthetic to reduce the pain associated with venipuncture in patients and prevent secondary complications.
Design
Clinical trial with control group, with parallel groups, blind, randomized
Settings and conduct
Emergency department patients are randomly divided into three equal groups.One of the three topical ointments marked with the number is rubbed in place and then the intravenous cannulation is taken to the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All alert adult patients admitted to the emergency department of Al-Zahra and Kashani hospitals and requiring venipuncture.
Exclusion criteria: The presence of visual, mental and verbal disorders - Addict in opioids - Sensitization to anesthetic drugs - Those who are in a life-threatening condition
Intervention groups
Patients over the age of 18 who are taking topical ketamine to reduce the pain associated with venipuncture
Main outcome variables
The severity of pain is measured based on the VAS scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N2
Registration date:2018-02-20, 1396/12/01
Registration timing:registered_while_recruiting
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of lidocaine-perilocaine cream with topical ketamine in reducing local pain in patients
Public title
Effect of topical ketamine on pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients referred to the emergency department of al-Zahra and Kashani hospitals
Need for Peripheral Intravenous Cannulation
Alert
Exclusion criteria:
The presence of visual, mental and verbal disorders
Opioids addiction
Sensitivity to anesthetic drugs
Patients in a life-threatening condition
Analgesic drug addict(More than 4 times a week)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly using computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
Ketamine ointment is prepared by a pharmacist and the same is packed with EMLA ointment, and then numbered and given to the nurse. The nurse and the physician and patient do not know the ointment content.
Placebo
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
Sofeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUI.REC.1396.3.029
Health conditions studied
1
Description of health condition studied
..
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The severity of pain
Timepoint
After intravenous cannulation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Time to start anesthetic effect
Timepoint
To an hour of exposure
Method of measurement
Time (minute)
2
Description
Drug side effects such as redness, whitening and skin blemishes
Timepoint
Until the time of discharge
Method of measurement
Observation
Intervention groups
1
Description
Patients are treated with EMLA cream. A 5%EMLA cream is a combination of 2.5% lidocaine and 2.5% perlocaine produced by Iranian chemistry company Iran. For each patient, 2 grams of 4 × 2.5 cm spam cream are applied and then covered with gas.Intervention group:
Category
Treatment - Drugs
2
Description
Intervention group: Patients treated with topical ketamine (vial 10 ml ketamine hydrochloride 50 mg / ml for i.m / i.v, TRITTAU made in Germany) are treated. To this end, we mixed the injection of 2cc ketamine with 10cc cold cream. Each cc of ketamine contains 50 mg. The solution thus obtained will have a concentration of 10 mg per cubic centimeter. Then, for each patient, we cover a cc of the solution made at the place to be taken and used for gas.
Category
Treatment - Drugs
3
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra and Kashani hospital
Full name of responsible person
Farhad Heydari
Street address
Alzahra Hospital,Sofeh Ave.,Shahid Keshvari Blvd
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Street address
Alzahra Hospital,Sofeh Ave.,Shahid Keshvari Blvd.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.,
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD