This study will be conducted at the Emergency Department of Taleghani Pediatric Medical Educational Center. For this, Eligible infants (one month to one-year-old) will be recruited. After obtaining the informed consent from parents/caregivers, they will be referred to the treatment room for venipuncture with one opaque envelope containing the group code. After opening the envelope by researcher and specify the group (placebo or Glucose solution), the interested solution will be feed by parents, two minutes before venipuncture. One skilled nurse who will be blinded about the groups is responsible for doing the venipuncture for all participants. During the first try for venipuncture, a cameraman will film from the infants' face. At the end of each day, two independent persons who are blind will observe the films and determine the pain score based on the FLACC.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
age: 1month-1year
Admitted at Taleghani Pediatric Medical Educational Center
Candidate for Peripheral Intravenous Catheterization
Excluding Criteria:
Emergency Situations
Suffering from life-threatening diseases
Intervention groups
ّFeed the Glucose solution 10%
Main outcome variables
The pain severity based on FLACC Score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140820018883N1
Registration date:2018-02-21, 1396/12/02
Registration timing:prospective
Last update:2018-02-21, 1396/12/02
Update count:0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Homeira Khoddam
Name of organization / entity
Golestan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3243 0353
Email address
khoddam@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Oral 10% Glucose solution with placebo in reducing pain due to venipuncture in Infants 1month to 1 year
Public title
Effectiveness of Oral 10% Glucose solution in reducing pain due to venipuncture in Infants 1month to 1 year
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age:one month to one year old
Need to indwelling catheter in Limb's'peripheral veins
Candidate for Intravenous Fluid Therapy
Informed consent of parents to participate the Infant
Exclusion criteria:
Disturbed of consciousness
Life threatening conditions (poisoning,..)
Age
From 1 month old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will assign participants in two groups by using block randomization technique.
Blinding (investigator's opinion)
Double blinded
Blinding description
The infant parents/ caregiver, the nurse responsible for intravenous catheterization (health care provider) and the persons (at least two) responsible for observing records and evaluating pain severity (Outcome assessors) will be blinded. In addition, we will conceal the intervention by using coded syringes (A and B) contain simple water (Placebo) and sweet solution with the same size, shape, and brand.
Placebo
Used
Assignment
Parallel
Other design features
To prevent researchers, Healthcare provider, and parents from predicting which infant will receive which solution (Placebo or intervention), we will conceal the allocation sequence by using opaque sealed envelopes. These contain the letters A (placebo) or B (Glucose). After obtaining informed consent from parents, they will be given an envelope to take with themselves to the treatment room, where the intervention will be applied. the researcher will open the envelope and based on the letters (A or B) will assign the infants into the groups. Two minutes before intervention the solution (Placebo or Intervention) will be feed to the infants and video recording will be started.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences Research Ethical Committee.
Street address
Hircan Boulvard.
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.GOUMS.REC.1396.268
Health conditions studied
1
Description of health condition studied
Venipuncture َacute pain in infants admitted to Emergency Department for acute diseases
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Acute pain due to venipuncture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity
Timepoint
two minutes before to two minutes after painful procedure (Venipuncture)
Method of measurement
FLACC (Face, Legs, Activity, Cry, CONSOLability) scoring system
Secondary outcomes
1
Description
Crying duration
Timepoint
from Intervention and two minute after that
Method of measurement
Observation and record by two independent observers
Intervention groups
1
Description
Intervention group: Including Eligible infants between one month and one year old admitted to Emergency Department of Hospital. They will receive 2 milliliters 10% glucose solution, one time, 2 minutes before venipuncture, orally. The researcher will draw Glucose solution into the uniform 2 milliliters syringes and will be coded(A) at the beginning of each day. The solution will be prepared by a pharmacist based on the researcher order.
Category
Prevention
2
Description
Control group: Including Eligible infants between one month and one year old admitted to Emergency Department of Hospital. They will receive 2 milliliters sterile water, one time, 2 minutes before venipuncture, orally. The researcher will draw sterile water into the uniform 2 milliliters syringes and encode(B) at the beginning of each day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Pediatric Medical Educational center
Full name of responsible person
Jabar Parhiz
Street address
Taleghani Pediatric Medical Educational center, Janbazan BLV
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3222 7720
Email
drparhiz2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammadreza Honarvar
Street address
Deputy of research and Technology, Golestan university of medical sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Homeira Khoddam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Nursing and Midwifery School, Golestan university of medical sciences, Falsafi Educational Campus, Hircan BLV.
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
khoddam@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Leila Barati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Golestan university of medical sciences, Falsafi Educational Campus, Hircan BLV
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 0225
Email
dr_l_barati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Homeira Khoddam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Nursing and Midwifery School, Golestan university of medical sciences, Falsafi Educational Campus, Hircan BLV
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
khoddam@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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