Protocol summary

Study aim
Comparing the effect of local anesthesia caused by intradermal injection of ketamine with lidocaine in venous venipuncture in the emergency department of Boali Hospital
Design
A clinical trial with a control group, with parallel groups, double-blind, phase 2 on 246 patients.
Settings and conduct
In group (a), 0.2 ml of buffered lidocaine, is injected intradermally. In group (b), we inject 0.2 ml of 1 mg ketamine solution intradermally, and in group (c) we inject 0.2 ml of normal saline. Venipuncture will be done After two to three minutes. The method of blinding is as follows: ketamine, lidocaine, and normal saline in 100 ml vials. The same will be poured and one of the letters a, b, c will be written on each one, and the patients will be randomly divided into three groups and receive a coded vial. Visual analog scale use for assessing patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the age range of 18-60 years, alertness and ability to communicate verbally, provide written consent and the need to take a venous vein under the supervision of a physician. Patients with unwillingness to continue to participate in the study, history of allergies to local anesthetics (lidocaine / prilocaine, tetracaine and benzocaine), opioid addiction, severe analgesia addiction, peripheral vascular diseases, sensory disorders such as diabetic neuropathy, cognitive disorders , And a history of needle phobias and panic attacks are excluded.
Intervention groups
246 people in three groups of 82 people are divided into 3 groups receiving buffered lidocaine, ketamine and placebo (normal saline).
Main outcome variables
the amount of pain caused by venipuncture, heart rate (dependent variables);

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200707048047N2
Registration date: 2022-09-07, 1401/06/16
Registration timing: registered_while_recruiting

Last update: 2022-09-07, 1401/06/16
Update count: 0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
Masoumeh Moallem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 6628
Email address
masoumehmoallem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-28, 1401/04/07
Expected recruitment end date
2022-10-29, 1401/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local anesthesia induced by intradermal injection of ketamine with lidocaine in intravenous venipuncture
Public title
Comparison of the effect of local anesthesia induced by intradermal injection of ketamine with lidocaine in intravenous venipuncture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
عدم تمایل بیمار به ادامه مشارکت در مطالعه سابقه حساسیت به بی حس کننده های موضعی ( لیدوکائین/پریلوکائین تتراکائین و بنزوکائین) اعتیاد به اپیوئیدها اعتیاد به ضد دردهای قوی مناسب نبودن عروق ناحیه آنته کوبیتال جهت رگ گیری بیماری های عروق محیطی اختلالات حسی مثل نوروپاتی دیابتی اختلالات شناختی سابقه فوبیا سوزن و حملات پانیک
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 246
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done in such a way that ketamine, lidocaine and normal saline are poured into similar 100 ml vials and each of the letters a, b, c is written and patients are randomly divided into three groups. Depending on whether they were in groups 1,2 or 3, they will receive a coded vial, and the researcher prescribing the drug is not aware of the type of drug, and later in the statistical analysis it will be determined which drug in each group Patients Nurses and data collectors do not know the type of substance used for each patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته‌ اخلاق در پژوهش دانشکده پزشکی- دانشگاه علوم پزشکی آزاد اسلامی تهران
Street address
khaghani
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.IAU.TMU.REC.1401.022

Health conditions studied

1

Description of health condition studied
venipuncture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of pain caused by venipuncture
Timepoint
Three minutes after the intervention
Method of measurement
Visual analog scale (VAS). (0-3) mild pain, (4-6) moderate pain and (10-7) severe pain.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention procedure: 0.2 ml of buffered lidocaine, which is obtained by adding two ml of 7.5% bicarbonate to twenty-two ml of 1% lidocaine, is injected intradermally. The second intervention group: 0.2 ml of 1 mg ketamine solution will be injected intradermally. After two to three minutes, the target area will be disinfected and the vein will be removed by professional nurses who did not know about the study. All cases of venipuncture are performed using venous catheter gage 21 in the area of ​​the middle cubital vein.Ketamine is a cyclohexanone derivative used to induce anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA (N-Methyl-D-Aspartate) receptors and may interact with sigma receptors. Lidocaine is a local anesthetic and cardiac depressant that is known as Antiarrhythmic agent is used. Its action is more intense and its effects are longer than the effects of procaine, but its duration of action is shorter than that of bupivacaine or prilocaine.Three vials of lidocaine 2% (50 ml) are used at the unit price of 1471000 Rial in Shahid Ghazi pharmaceutical company, built inside. Ketamine vials of 50 mg/ml (10 ml) are three units at the unit price of 3500000 in the pharmaceutical company. Internally made elixir is used. 246 pink venous catheter are used at the unit price of 33,000 Rial made by Polymed. 246 sets of serums are used at a unit price of 55,000 Rial made by Polymed.
Category
Treatment - Drugs

2

Description
Control group: Control group: 0.2 ml of normal saline will be injected intradermally and after two to three minutes the target area will be disinfected and the vein will be removed by professional nurses who were not aware of the study. All cases of venipuncture are performed using venous catheter gage 21 in the area of ​​the middle cubital vein. Injectable normal saline is used in four units at the price of 184,800 Rial, the Iranian injectable and medicinal products.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Boali hospital Tehran
Full name of responsible person
Masoumeh moallem
Street address
Boali hospital,Damavand st,Imam Hosein sq,Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
masoumehmoallem@gmail.com
Web page address
http://bouali.iautmu.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Khoshdel
Street address
khaghani
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
pezeshkitehran.8@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Islamic Azad University
Full name of responsible person
masoumeh moallem
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Dastgerdi
City
Tehran
Province
Tehran
Postal code
1918613511
Phone
+98 21 2222 3567
Email
masoumehmoallem@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shimaa Mosalanejad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Khaje abdollah
City
tehran
Province
Tehran
Postal code
1661645320
Phone
+98 21 2232 2780
Email
shimaamosalanejad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
masoumeh moallem
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Dastgerdi
City
Tehran
Province
Tehran
Postal code
1918613511
Phone
+98 21 2222 3567
Email
masoumehmoallem@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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