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IRCT2014122610279N4 IRCT 2015-01-26 Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy Sucrose role in the pain control during eye examination Comparing the effect of repeated low dose and unique high dose sucrose with placebo (distilled water) on the control of pain secondary to retinopathy of prematurity examination of premature neonates 2010-12-01 anticipated 64 Complete https://irct.ir/trial/10744 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Neonates were divided by three group; group 1 (Placebo group): Neonates who were given 0.2 ml distilled water 2 minutes before, during, and after the procedure by 2 minutes interval (n= 21); group 2: Neonates who were given 0.2 ml 24% sucrose 2 minutes before, during, and after the procedure (n= 22); group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure (n= 21). Neonates were randomly assigned to one of three treatment groups, using a computer generated randomization programme. The packed colorless study solutions were provided by the pharmacy in sealed envelopes to the patient’s nurse 3 minutes before the examination. The nurse, ophthalmologist, and investigators and the parents were blinded to the group assignment. Tropicamide (0.5%) and fenilefrin HCL were dropped to the eyes 2 times (10 minute interval) 60 minutes before eye examination, and local anesthetic medicine (Proparacaine; Alcaine drop 0.5%) were dropped to the eyes 30 minutes before the examination. Each neonate was equipped with an oxisensor connected to a Nelcor pulse oximeter (Ovidien RMS). 3 Retinopathy of prematurity. Intervention 1: Group 1(Placebo group): Neonates who were given 0.2 ml distilled water 2 minutes before, during, and after the procedure by 2 minutes interval. Intervention 2: Group 2: Neonates who were given 0.2 ml 24% sucrose 2 minutes before, during, and after the procedure. Intervention 3: Group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure.
public Derya Benzer
No:3-4, Dr. Burhanettin Ustünel Sok., Zeynep Kamil Mah.
Istanbul Turkey 34668 0090 216 391 06 80 dbenzer@yahoo.com Zeynep Kamil Maternity and Children's Education and Training Hospital scientific Guner Karatekin
No:3-4, Dr. Burhanettin Ustünel Sok., Zeynep Kamil Mah.
Istanbul Turkey 34668 0090 216 391 06 80 gunerkaratekin@yahoo.com Zeynep Kamil Maternity and Children's Education and Training Hospital Turkey Inclusion criteria; 1. Premature neonates who underwent first retinopathy of prematurity examination Exclusion criteria; 1. Invasive or noninvasive mechanical ventilation therapy during retinopathy of prematurity examination. 2. Neonates who take analgesia, sedative medicine. 3. Asphyxia 4. Intraventricular hemorrhage 5. Neonates who were resuscitated 6. Neonates who had congenital anomaly 28 days 2 months Both H35-1 Retinopathy of prematurity Placebo Other Other Group 1(Placebo group): Neonates who were given 0.2 ml distilled water 2 minutes before, during, and after the procedure by 2 minutes interval Group 2: Neonates who were given 0.2 ml 24% sucrose 2 minutes before, during, and after the procedure Group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure Premature infant pain scale (PIPP). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records. Frequency of tachycardia (>180 bpm). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records. Frequency of bradycardia (<100 bpm). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records. Desaturation (<85% for 10 second). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records. Crying time. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records. Degree of cry. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records. Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy Approved 2010-12-27 Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy No:5, 2176 Sok., Sögütözü Mah Ankara Sögütözü Turkey