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IRCT2014122610279N5 IRCT 2015-02-24 Health Ministry Drug and Pharmacy General Management Swaddle and/or sucrose role in the pain control during eye examination Comparing the effect of swaddle and sucrose combination with unique effect of both swaddle, sucrose or placebo on the control of pain secondary to retinopathy of prematurity examination of premature neonates 2010-12-01 anticipated 83 Complete https://irct.ir/trial/10745 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Other design features: Neonates were divided by four group; group 1(Placebo group): Neonates who were given distilled water 2 minutes before the procedure (n= 21); group 2: Neonates who were swaddled 15 minutes before the procedure (n= 20); group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure (n= 22); group 4: Neonates who were swaddled 15 minutes before the procedure and who were given 0.6 ml 24% sucrose 2 minutes before the procedure (n= 20). Neonates were randomly assigned to one of four 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: Neonates who were given distilled water 2 minutes before the procedure. Intervention 2: Neonates who were swaddled 15 minutes before the procedure. Intervention 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure. Intervention 4: Neonates who were swaddled 15 minutes before the procedure and who were given 0.6 ml 24% sucrose 2 minutes before the procedure.
public Derya Benzer
No:3-4, Dr. Burhanettin Üstünel Sokak., 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 Üstünel Sokak., 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 Other Neonates who were given distilled water 2 minutes before the procedure Neonates who were swaddled 15 minutes before the procedure Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure. Neonates who were swaddled 15 minutes before the procedure and 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. 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. Desaturation (<85% for 10 seconds). 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. 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. 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. Health Ministry Drug and Pharmacy General Management Approved 2010-12-27 Zeynep Kamil Maternity and Children's Education and Training Hospital Ethical Committee No:3-4, Dr. Burhanettin Üstünel Sokak., Zeynep Kamil Mahallesi Istanbul Uskudar Turkey