The effect of oral glucose solution on pain during circumcision in infants
Design
A prospective randomized controlled clinical trial, phase 3, is conducted on 60 infants who are refered for circumcision by ring insertion.Patients are randomly allocated in two groups by using of permuted block randomization.
Settings and conduct
Eligible patients referred to Kosar Hospital in Semnan will be evaluated after assigning to the intervention or control group. Before and during circumcision, the duration of crying, and the pain score based on Neonatal-Infant Pain Scale are recorded for each infant.
Participants/Inclusion and exclusion criteria
Infants, aged one to 12 months who refer for circumcision and are candidates for circumcision by inserting a ring (Plastibell) will be enrolled.
Intervention groups
In both groups, lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, infants in the intervention group will receive 2 cc of glucose 50% solution and control group 2cc of distilled water. Circumcision is performed 5 minutes after the onset of anesthesia.
Main outcome variables
Pain score based on Neonatal-Infant Pain Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N14
Registration date:2021-06-18, 1400/03/28
Registration timing:prospective
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral glucose solution for pain control during infant circumcision by ring method (Plastibell)
Public title
Evaluation of the effect of oral glucose solution for pain control during infant circumcision
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infant candidate for circumcision by placing a ring (Plastibell)
Exclusion criteria:
There is not any exclusion criteria
Age
From 1 month old to 12 months old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a block randomization method will be used. In the study, The allocation of samples is based on a random sequence provided by a statistical expert using statistical software. The block size will be 6. Meanwhile, the tool which is used for generating random-sequence blocks is a web-based software available at https://kitset.ir/numbers/random.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Central office of Semnan University of Medical Sciences, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.SEMUMS.REC.1399.340
Health conditions studied
1
Description of health condition studied
Pain of incision site
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain score
Timepoint
Before and during circumcision, every one minute
Method of measurement
Neonatal Infant Pain Scale
2
Description
Duration of crying
Timepoint
Before and during circumcision.
Method of measurement
Measurment by chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, 2cc of glucose solution 50% is orally feed. Circumcision is performed 5 minutes after the onset of anesthesia.
Category
Treatment - Other
2
Description
Control group: Lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, 2 cc of distilled water is orally feed. Circumcision is performed 5 minutes after the onset of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mahshid Ghasemzadeh
Street address
Amin Avenue, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2021
Email
mahshid.gh1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei MD
Street address
Central office of Semnan University of Medical Sciences, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
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
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchman
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Basidj Boulevard, Amin Ave.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2252
Email
mehrdadzahmatkesh@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany MD
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Basidj Boulevard, Amin Ave.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
setarehsoltany@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchman
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Basidj Boulevard, Amin Ave.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3141 2252
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Anonymised data will be offered.
When the data will become available and for how long
After publishing of final report
To whom data/document is available
Researcher who working in academic institutions
Under which criteria data/document could be used
Referees and competent people
From where data/document is obtainable
For this purpose, the applicant can send an official correspondence.
What processes are involved for a request to access data/document