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
A clinical trial with the control group, with parallel groups, blind randomized
Settings and conduct
After obtaining the code of ethics from the ethics committee of Isfahan University of Medical Sciences and obtaining written consent from 201 eligible patients, they are divided into three groups using a computer-generated random number table with 4 blocks. In the first group painless spray and in the second group cold compress and in third group placebo are applied. After 10 min intravenous cannulation is inserted. Patients' pain score during intravenous cannulation placement is determined and recorded based on NAS from 0 to 10.
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 - Sensory and motor disorders of the upper extremities - Sensitization to anesthetic drugs - Those who are in a life-threatening condition
Intervention groups
Patients over the age of 18 who are taking painless spray to reduce the pain associated with venipuncture
Main outcome variables
The severity of pain is measured based on the NAS scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N13
Registration date:2021-12-11, 1400/09/20
Registration timing:registered_while_recruiting
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
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
2021-12-01, 1400/09/10
Expected recruitment end date
2022-04-30, 1401/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Pain Less Spray and cold compress on reducing pain caused by venipuncture in patients admitted to the emergency room
Public title
Evaluation of the effect of painless spray in reducing local pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients referred to the emergency department of al-Zahra and Kashani hospitals Need for Central Venous Catheter Insertion
Alert
Stable vital signs
Exclusion criteria:
The presence of visual, mental and verbal disorders
Sensitivity to anesthetic drugs
Sensory or motor disorder of the upper extremities
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
After the arrival of the patients to the emergency department, they are divided into 3 groups by a computer-generated random number table with 4 blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the group receiving Pain Less Spray, this spray is used ten minutes before venipuncture of the upper limb at the site of venipuncture.
In the group receiving a cold compress, ten minutes before the venipuncture, the cold compress is placed at the venipuncture site.
Saline spray is also used in the control group. After 10 minutes in all three groups, venipuncture is performed from the back of the hand by one of the three skilled nurses previously identified. All cases of venipuncture are performed with a catheter number 20. The research physician and the nurse who performs the venipuncture do not know which group the patient is in.
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
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.MUI.MED.REC.1400.512
Health conditions studied
1
Description of health condition studied
Procedural pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The severity of pain
Timepoint
After intravenous cannulation
Method of measurement
Numeric Analogue Scale (NAS)
Secondary outcomes
1
Description
Drug side effects such as redness, whitening and skin blemishes
Timepoint
Until the time of discharge
Method of measurement
Standard questionnaire form
Intervention groups
1
Description
Intervention group: A puff of painless spray is used ten minutes before venipuncture of the upper limb at the site of venipuncture. The intravenous cannulation is inserted in back of the hand by one of the three previously identified skilled nurses.
Category
Treatment - Drugs
2
Description
Intervention group: A cold compress is used ten minutes before venipuncture of the upper limb at the site of venipuncture. The intravenous cannulation is inserted in back of the hand by one of the three previously identified skilled nurses.
Category
Treatment - Drugs
3
Description
Control group: A puff of saline spray is used ten minutes before venipuncture of the upper limb at the site of venipuncture. The intravenous cannulation is inserted in back of the hand by one of the three previously identified skilled nurses.