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IRCT20220703055360N1 IRCT 2023-02-14 Alborz University of Medical Science The efficacy of sucrose for relieving lumbar puncture pain in neonates of Kamali hospital in Karaj, randomized clinical trial The efficacy of sucrose for relieving lumbar puncture pain in neonates of Kamali hospital in Karaj, randomized clinical trial 2023-02-20 anticipated 60 Complete https://irct.ir/trial/64590 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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. 3 pain control. Intervention 1: Intervention group: The group that is given 2 cc of oral 25% sucrose. Intervention 2: Control group: The group that is given 2 cc of distilled water. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Alireza Jashni Motlagh
Beheshti Ave, Kamali hospital
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 sinamashayekhi13760911@gmail.com Alborz University of Medical Science scientific Alireza Jashni Motlagh
Beheshti Ave, Kamali hospital
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 sinamashayekhi13760911@gmail.com Alborz University of Medical Science Iran (Islamic Republic of) being term (in neonates) age under 28 days no fever (body temperature under 38 centigrade) no feeding before 30 minutes before studying 1 day 28 days Both having congenital anomalies having metabolic diseases G89 Pain, not elsewhere classified Treatment - Drugs Placebo Intervention group: The group that is given 2 cc of oral 25% sucrose Control group: The group that is given 2 cc of distilled water Neonatal infant pain score (NIPS). Timepoint: before, first minute and third minute. Method of measurement: 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. Alborz University of Medical Science Approved 2023-01-18 Ethics committee of Alborz university of medical science Beheshti Ave, Seyed-Alshohada Ave, Kamali hospital Karaj Alborz Iran (Islamic Republic of)