A comparison between the effectiveness and safety of the combination of Licodain spray and vapocolant spray, and Licodain spray alone in local anesthesia during iv catheterization
Determining and comparing the local anesthetic effect of lidocaine spray along with Power Ice Deltazax cooling spray with lidocaine spray during venous catheterization
Design
A controlled, parallel-group, single-blind clinical trial.
Randomized phase 2 on 116 patients
Dice is used for randomization.
Settings and conduct
Boali hospital emergency room,
The samples were divided into 2 groups: 1- intervention with lidocaine spray along with Deltazax PowerIce cooling spray and 2- intervention group with lidocaine spray alone.
Blinding is one-way blinding and the patient does not know the group he is in and the medicine used
Participants/Inclusion and exclusion criteria
- Criteria for entering the study:
Patients requiring intravenous injections
Age above 18 years
Alert and able to communicate
No history of psychiatric disorders
Do not use any topical medication
Do not take painkillers for 12 hours before venipuncture
Willingness and informed consent to participate in the study
- Exclusion criteria:
Lack of consent to enter the study
Addiction to opioids
Addiction to strong painkillers
History of allergy to any of the drugs used
Sensitivity to cold
A history of panic attacks
Patients with peripheral vascular diseases
Patients with sensory disorders such as peripheral neuropathy
Unwillingness to continue participating in the study
Intervention groups
1- the intervention with lidocaine spray along with PowerIce Deltazax cooling spray
2- the intervention group with lidocaine spray alone will be divided.
Main outcome variables
intensity of pain،
Increased heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200707048047N3
Registration date:2023-03-01, 1401/12/10
Registration timing:registered_while_recruiting
Last update:2023-03-01, 1401/12/10
Update count:0
Registration date
2023-03-01, 1401/12/10
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
2023-02-05, 1401/11/16
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effectiveness and safety of the combination of Licodain spray and vapocolant spray, and Licodain spray alone in local anesthesia during iv catheterization
Public title
The effect of lidocaine spray and vapocolant spray in reducing the pain of venous catheterization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and informed consent to participate in the study
Age above 18 years
Alert and able to communicate
No history of psychiatric disorders
Do not use any topical medication
Do not take painkillers for 12 hours before venipuncture
Willingness and informed consent to participate in the study
Exclusion criteria:
Lack of consent to enter the study
Addiction to opioids
Addiction to strong painkillers
History of allergy to any of the drugs used
Sensitivity to cold
A history of panic attacks
Patients with peripheral vascular diseases
Patients with sensory disorders such as peripheral neuropathy
Unwillingness to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method will be divided into 2 groups: 1- intervention with lidocaine spray along with Deltazax Powerice cooling spray and 2- intervention group with lidocaine spray alone. In order to randomly select 2 groups, dice will be used. Each of the samples will be placed in intervention group 1 if features 1, 2, 3 occur, and in intervention group 2 if features 4, 5, 6 occur. In the next step, the letter A (meaning intervention group 1) and letter B (meaning intervention group 2) will be placed in the envelope based on the choice made. For the first eligible person, envelope number one will be completed, and the envelopes will be given to the participants in order of number. and after opening the envelope, the type of individual group (intervention 1 and 2) was specified
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is one-way blinding and the patient does not know the group she is in and the medicine used
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Tehran Medical Sciences Branch
Street address
Khaghani
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.IAU.TMU.REC.1401.179
Health conditions studied
1
Description of health condition studied
Reduce the pain of iv catheterization
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity during venipuncture
Timepoint
Immediately after venipuncture
Method of measurement
visual analog scale (VAS), 0-3 is mild pain, 4-6 is moderate pain, and 7-10 is severe pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: intervention with lidocaine spray along with Deltazax Power Ice cooling spray, for this group, 10 puffs equivalent to 100 mg of 10% lidocaine solution (manufactured by Iran Daru Company) along with 10 puffs of Power Ice Deltazax cooling spray (manufactured by Delta Daru Company) for a period of It will be used for 5 minutes on the location of vein extraction in a circle with a diameter of 3 cm. After two to three minutes, the target area will be disinfected with cotton and alcohol to a diameter of 5 cm. After 60 seconds, the vein will be taken by professional nurses. It will be done.All cases of venipuncture are performed with angioket number 21 in the middle cubital vein area. Lidocaine spray is an effective painkiller in mucous membranes، Lidocaine topical solution spray is one of the common forms of lidocaine for clinical use. Lidocaine spray has a medium effect and is used for local anesthesia of mucous membranes and skin. Cooling spray is an aerosol spray containing a volatile gas that evaporates in contact with the skin, its cooling effect is used to relieve pain.10% lidocaine spray is used at the price of 473,000 rials per unit. Power Ice Deltasex cooling spray is used for five units at the price of 620,000 rials per unit.
Category
Treatment - Drugs
2
Description
Intervention group 2: The intervention group is with lidocaine spray alone, in this group, 10 puffs equivalent to 100 mg of 10% lidocaine solution (manufactured by Iran Daro Company) alone for 5 minutes on the venipuncture site in a circular manner with a diameter of 3 cm meter will be used. After two to three minutes, the desired area will be disinfected with cotton and alcohol to a diameter of 5 cm, and after 60 seconds, the vein will be taken by professional nurses. It is performed in the middle cubital vein area. Lidocaine spray is an effective pain reliever for mucous membranes،Lidocaine topical solution spray is one of the common forms of lidocaine for clinical use. Lidocaine spray has a medium effect and is used for local anesthesia of mucous membranes and skin.. Lidocaine spray 10% is used at the price of 473,000 rials per unit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان بوعلی
Full name of responsible person
Masoumeh moallem
Street address
Tehran, Imam Hossein Square, the beginning of Damavand St
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Fax
+98 21 3378 6182
Email
booali.hospital96@gmail.com
Web page address
https://tms.iau.ir/bouali/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
Fax
+98 21 2660 2642
Email
Pezeshkitehran.8@gmail.com
Web page address
https://tms.iau.ir/fa
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 Moallm
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Vahid 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
Shima mosalanejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Khage abdolah
City
Tehran
Province
Tehran
Postal code
16611645320
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
Assocuate professor
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
Vahid 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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD