The aim of this study was to determine the effect of lidocaine 2% gel on intensity of pain during testing and intramuscular Benzathin (1/200/000 u) injection. In this clinical trial, 60 patients for whom injection of Benzathin Penicillin had been prescribed were chosen and randomly assigned into intervention or control. The patients in the intervention group lidocaine 2% gel was applied 10 minutes before testing at the site of intramuscular injection while in the control group, routine testing and IM injection was performed. Intensity of pain was measured using Visual Analogue Scale (VAS) and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904024247N1
Registration date:2009-05-22, 1388/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-22, 1388/03/01
Registrant information
Name
Abolfazl Farhadi
Name of organization / entity
Islamic Azad University, Shirvan Branch,
Country
Iran (Islamic Republic of)
Phone
+98 58 5624 3903
Email address
a_farhadi@iau-shirvan.ac.ir
Recruitment status
Recruitment complete
Funding source
Shirvan branch, Azad Islamic University
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2009-09-24, 1388/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lidocaine 2% gel on severity of pain during testing and intramuscular penicillin Benzathin (1/200/000 U ) injection
Public title
Effect of Lidocaine 2% gel on severity of pain during testing and intramuscular penicillin Benzathin (1/200/000 U ) injection
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age 15-50 years, prescription of injection of penicillin by a physician, no other injections prescribed, full consciousness,
Exclusion criteria: any other pain before injection, blocked needle leading to a delay during injection, communication difficulties, presence of severe pain due to other cause, presence of diabetes mellitus, presence of any sensory-motor disorders, any other problem at the site of injection, receiving penicillin injection during 6 months prior to the study
Age
From 16 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ninth region, Islamic Azad University
Street address
No. 225, Chamran St.
City
Mashhad
Postal code
94617
Approval date
empty
Ethics committee reference number
09/88/5/1385
Health conditions studied
1
Description of health condition studied
pain during testing and intramuscular penicillin Benzathin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
5 minate after penicillin testing or IM injection
Method of measurement
Visual Analouge Scale ( VAS )
Secondary outcomes
empty
Intervention groups
1
Description
Applying 3 grams lidocaine 2% gel in 9 cm area, 10 minutes before testing or IM injection and then testing or intramuscular injection of Penicillin Benzathin 1200000 u
Category
Treatment - Drugs
2
Description
Testing or intramuscular injection of Penicillin Benzathin 1200000 u
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Rohani
Street address
Imam Reza St
City
Shirvan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Shirvan Branch
Full name of responsible person
Dr Mehdi Vatanparast
Street address
Islamic Azad University, Shirvan Branch, University St
City
Shirvan
Grant name
پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Shirvan Branch
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
Full name of responsible person
Abolfazl Farhadi
Position
Master of Nursing/ Reasercher Assistant
Other areas of specialty/work
Street address
Islamic Azad University, Shirvan Branch, University St
City
Shirvan
Postal code
94617
Phone
+98 58 5624 3903
Fax
Email
a_farhadi@iau-shirvan.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Full name of responsible person
Abolfazl Farhadi
Position
Master of Nursing
Other areas of specialty/work
Street address
Islamic Azad University, Shirvan Branch, University St
City
Shirvan
Postal code
94617
Phone
+98 58 5624 3903
Fax
Email
a_farhadi@iau-shirvan.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Abolfazl Farhadi
Position
Other areas of specialty/work
Street address
City
Postal code
94617
Phone
+98 58 5624 3903
Fax
Email
a_farhadi@iau-shirvan.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)