After obtaining the code of ethics from the ethics committee of Isfahan University of Medical Sciences and obtaining written consent from 108 eligible patients, they are divided into two groups. In the first group ice cube and in the second group placebo are applied. In the intervention group, an ice cube measuring 2 × 2 × 2 cm (at 0 ° C) in sterile gloves are placed on the wound for 2 minutes, and then buffered lidocaine injection is performed. Immediately after injection, each patient was evaluated to rate the pain using the visual analogue scale (VAS) 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 lidocaine injection. Exclusion criteria: The presence of visual, mental, and verbal disorders; History of peripheral neuropathy; Allergic reaction to local anesthetics; Those who are in a life-threatening condition.
Intervention groups
In the case group, local ice cubes with zero temperature are used to reduce the pain caused by lidocaine injection, and in the control group, no action is taken before lidocaine injection.
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:IRCT20180129038549N14
Registration date:2021-12-15, 1400/09/24
Registration timing:registered_while_recruiting
Last update:2021-12-15, 1400/09/24
Update count:0
Registration date
2021-12-15, 1400/09/24
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
2021-12-06, 1400/09/15
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Local skin cooling to reduce pain associated with local buffered lidocaine infiltration
Public title
Effect of local cooling in pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients referred to the emergency department
Willing to participate in the study
Superficial wound/laceration of arm/forearm, ≤5 cm2
Alert
Exclusion criteria:
Visual, mental, or verbal disorders
Multiple trauma
Unstable vital sign
A history of peripheral neuropathy
A history of an allergic reaction to local anesthetics
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
After the arrival of the patients to the emergency department, they are divided into 2 groups by a computer-generated random number table with 4 blocks.
The selected subjects will be divided into each study group in a randomized block method using 6 rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). Ice cube group (A) and control group (B). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
A trained operating room technician performs local cooling in the case group. The wounds of patients in both groups are repaired by the doctor's colleagues and then all the information is collected by a researcher who was blinded to randomization.
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 Science
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-02, 1398/03/12
Ethics committee reference number
IR.MUI.MED.REC.1398.278
Health conditions studied
1
Description of health condition studied
Lidocaine injection pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
The severity of pain
Timepoint
After lidocaine injecton
Method of measurement
Visual Analogue Scale
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: In the intervention group, an ice cube measuring 2 × 2 × 2 cm (at 0 ° C) in sterile gloves is placed on the wound for 2 minutes, and then buffered lidocaine injection is performed. Immediately after injection, each patient is evaluated to rate the pain using the visual analogue scale (VAS) from 0 to 10.
Category
Treatment - Drugs
2
Description
Control group: In the control group, no ice cube is used before injecting buffered lidocaine.