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IRCT20201004048918N1 IRCT 2020-11-02 Islamic Azad University Comparison of the effect of sucrose and glucose on neonatal pain Comparison of the effect of sucrose and glucose on neonatal pain during invasive procedures in the neonatal intensive care unit of Kashan Beheshti Hospital 2020-03-20 anticipated 60 Complete https://irct.ir/trial/51441 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The study is double-blind.Sucrose is indicated by code A and glucose by code B.Participants in this study and nurses who assist in gathering information are unaware of the type of solutions. Only the researcher knows the type of solutions. 2 Infants admitted to the hospital with respiratory problems, premature infants, low birth weight. Intervention 1: Intervention group 1:The group receiving sterile sucrose 24% , which will be prepared as a package of 5 ml polyethylene ampoule from Shahid Ghazi Pharmaceutical Company located in Tabriz.And will be used orally with a syringe and without a needle head.2 minutes before the invasive procedure,An amount of 0.1 to 2 cc of 24% sucrose solution is injected on the anterior surface of the baby's tongue.The procedure is then performed and the pain score is measured.The maximum effect of sucrose is up to 5 minutes.If the procedure is prolonged, the dose can be repeated. Intervention 2: Intervention group 2:The group receiving glucose.20% liquid glucose will be provided by Shahid Ghazi Pharmaceutical Company located in Tabriz and will be used orally using a needleless syringe.2 minutes before the invasive procedure,0.1 to 2 cc of glucose 20 solution is injected on the anterior surface of the baby's tongue.The procedure is then performed and the pain score is measured.The baby will be monitored for 30 seconds.The maximum effect of glucose is up to 5 minutes.If the procedure is prolonged, the dose can be repeated. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient information is confidential and non-disclosable. No further information available.
public Maasoumeh Barkhordari
Safaieh, Boulevard of the Unknown Martyrs
Yazd Iran (Islamic Republic of) 8915813135 +98 35 3821 1391 Barkhordari-m@gmail.com Islamic Azad University scientific Maasoumeh Barkhordari
Safaieh, Boulevard of the Unknown Martyrs
Yazd Iran (Islamic Republic of) 8915813135 +98 35 3821 0540 Barkhordari-m@gmail.com Islamic Azad University Iran (Islamic Republic of) Hospitalization of infants in the neonatal intensive care unit Gestational age of 27 to 40 weeks Existence of swallowing and sucking reflex no limit 28 days Both Feed the baby 30 minutes before the injection Take acetaminophen on the same day Opioid use by the mother Existence of cardiorespiratory, developmental and neurological problems Lack of gag reflex Receive naloxone or phenobarbital in the last 48 hours Prevention Prevention Intervention group 1:The group receiving sterile sucrose 24% , which will be prepared as a package of 5 ml polyethylene ampoule from Shahid Ghazi Pharmaceutical Company located in Tabriz.And will be used orally with a syringe and without a needle head.2 minutes before the invasive procedure,An amount of 0.1 to 2 cc of 24% sucrose solution is injected on the anterior surface of the baby's tongue.The procedure is then performed and the pain score is measured.The maximum effect of sucrose is up to 5 minutes.If the procedure is prolonged, the dose can be repeated. Intervention group 2:The group receiving glucose.20% liquid glucose will be provided by Shahid Ghazi Pharmaceutical Company located in Tabriz and will be used orally using a needleless syringe.2 minutes before the invasive procedure,0.1 to 2 cc of glucose 20 solution is injected on the anterior surface of the baby's tongue.The procedure is then performed and the pain score is measured.The baby will be monitored for 30 seconds.The maximum effect of glucose is up to 5 minutes.If the procedure is prolonged, the dose can be repeated. Reduce pain in infants. Timepoint: Measurement of pain when performing 3 invasive procedures on infants.Includes venous venipuncture, arterial blood draw, lumbar puncture. Method of measurement: Use of infant pain measurement tools-pipp. Islamic Azad University Approved 2020-09-19 Islamic Azad University-Isfahan Branch (Khorasgan) East Jay St. - Purple - University Blvd. Esfahan Isfehan Iran (Islamic Republic of)