The evaluation of effect of cold application over skin on the change of pain level during the injection of local anesthetic drugs in patients with skin laceration
The objective of the study is to evaluate the effect of local cold application on the the pain produced by the injection of local anesthetic drug. 90 people referring to Rasoul Akram and Sian emergency departments who have found laceration anywhere in their skin. First, the pain level of injured area will be measured by visual analogue scale (VAS) score. Then, the patients will be divided to case and control groups by numerical random scale. Cold will be applicated over the affected area for 5 minutes just for the case group. Then, 1% lidocain solution will be injected through a 20 G needle to anesthesize the area. The pain produced by injection will be measured again by VAS score and will be compared to the initial pain. The change in pain level will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307238543N4
Registration date:2014-11-28, 1393/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Babak Mahshidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2221
Email address
b-mahshidfar@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Iran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of cold application over skin on the change of pain level during the injection of local anesthetic drugs in patients with skin laceration
Public title
The effect of cold application on the skin upon the pain produced by the injection of local anesthetic drugs.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: acute skin laceration needing local anesthetic injection; age over 8
Exclusion criteria: Intolerable and intense pain; having severe injuries and fractures in other sites of the body; serious and extensive skin illness; neurological or psychological disorders; use of other local or systemic sedative drugs; skin allergy to cold
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Medical College, Hemmat Highway
City
Tehran
Postal code
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
8635
Health conditions studied
1
Description of health condition studied
pain of injection of local anesthetic drugs.
ICD-10 code
S01, S11,
ICD-10 code description
Open wound of head, Open wound of neck, Open wound of thorax, Open wound of abdomen, lower back and pelvis, Open wound of shoulder and upper arm, Open wound of forearm, Open wound of wrist and hand, Open wound of hip and thigh, Open wound of lower leg, O
Primary outcomes
1
Description
Pain Severity
Timepoint
Before, during and after administration of Ice compress
Method of measurement
Administration of Visual Analogue Scale
Secondary outcomes
1
Description
increase of pain
Timepoint
post intervention
Method of measurement
visual analog scale
Intervention groups
1
Description
in intervention group, dry ice will be used for 5 minutes on the wound site.
Category
Other
2
Description
control group will not receive any intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Hazrate Rasool (S) Educational-Therapeutic Centre
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Emergency Department of Haft-e-Tir Hospital
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Emergency Department of Firoozgar Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi. MD
Street address
Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Assistant Professor
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Niayesh St. Satarkhan st.
City
Tehran
Postal code
Phone
+216 652327
Fax
Email
bmahshidfar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Nyayesh St. Satarkhan st.
City
Tehran
Postal code
Phone
+66 52327
Fax
Email
bmahshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Nyayesh St. Satarkhan st.
City
Tehran
Postal code
Phone
+66 52327
Fax
Email
bmahshidfar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)