Determining the efficacy of sucrose for relieving lumbar puncture pain in neonates of Kamali hospital, randomized clinical trial
Design
A randomized controlled trial with a control group, with parallel groups, the double-blind, phase 3, will be conducted on 60 LP candidate infants. Pre-randomization list with https://www.sealedenvelope.com/simple-randomiser/v1/lists The use of web software will be provided with an email address.
Settings and conduct
the study will be performed on neonates who are candidates for lumbar puncture in Kamali hospital in Karaj city.
Participants/Inclusion and exclusion criteria
age under 28 days, being the term
Intervention groups
the precipitant neonates will divide into two groups, one group will receive 2cc of oral sucrose 25% and the other group will receive 2cc of oral Distilled water
Main outcome variables
NIPS (neonatal infant pain score) and physiological criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220703055360N1
Registration date:2023-02-14, 1401/11/25
Registration timing:prospective
Last update:2023-02-14, 1401/11/25
Update count:0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Sina Mashayekhi Poor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 6926
Email address
sinamashayekhi13760911@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of sucrose for relieving lumbar puncture pain in neonates of Kamali hospital in Karaj, randomized clinical trial
Public title
The efficacy of sucrose for relieving lumbar puncture pain in neonates of Kamali hospital in Karaj, randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being term (in neonates)
age under 28 days
no fever (body temperature under 38 centigrade)
no feeding before 30 minutes before studying
Exclusion criteria:
having congenital anomalies
having metabolic diseases
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Considering that the study participants are neonates, the study is double-blinded.In order to randomize the studied groups, using the block randomization method with size Unmatched blocks for assigning samples to one of the two desired intervention groups (the group we give sucrose to) and the control group (the group to which we give sterile distilled water) will be used. Pre-randomization list with
https://www.sealedenvelope.com/simple-randomiser/v1/lists Using web software with the email address will be prepared and the researcher who is not involved in the patient selection and allocation process will have access to this form. Block sizes 2, 4, and 6 will be selected.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz university of medical science
observation of neonate and Measurement of NIPS and physiologic criteria. This criterion includes examining facial changes, crying, breathing pattern, motor activity, and arousal state. Facial changes include two points, if there are loose muscles and a relaxed face, zero points are given, and if there are any of the changes such as contraction of facial muscles, pulling together eyebrows, chin, or jaw, one point is given. The quality of crying is also given three points including zero points in case of no crying, point one in case of brief and intermittent crying, and point two in case of excessive, continuous, loud crying. Breathing status includes zero scores in case of any change in the normal breathing status such as holding the breath, breathing faster than usual, and irregular breathing. condition of upper and lower limbs; Each of them will receive a score of zero in the presence of muscle stiffness and accidental movements of the limbs, and a score of one in the presence of muscle stiffness and rapid bending and straightening movements; and to the state of consciousness; If there is no change in sleeping or waking state, a score of zero is given, and if there is any restlessness, a score of one is given. The physiological criteria (O2 saturation) studied include heart rate, breathing rate, and blood oxygen saturation percentage
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that is given 2 cc of oral 25% sucrose
Category
Treatment - Drugs
2
Description
Control group: The group that is given 2 cc of distilled water