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IRCT2014101919589N1 IRCT 2014-12-12 Vice-chancellor for research- Mashhad University of Medical Sciences, Mashhad, Iran Effect of breast feeding and Sucrose on pain relief in neonates Comparison survey between breast feeding and Sucrose on pain relief and physiological parameters during capillary sampling in neonates: A randomized controlled trial 2014-12-22 anticipated 95 Complete https://irct.ir/trial/17501 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Acute pain. Intervention 1: 2 ml of sterile water as placebo will be prepared and syringed in anterior part of the tongue 2 minutes before sampling. Intervention 2: 2 ml sucrose 25% will be prepared in advance and syringed in anterior part of tongue 2 minutes before sampling. Intervention 3: Infants will be breastfed in kangaroo care. Breastfeeding will be started 2 minutes before sampling and continue during the sampling. Infants are dressed, thus there is no skin to skin contact with mother. Mothers are not allowed to speak with their babies nor swaddle them.
public Emadodin Darchini-Maragheh
Medical Toxicology Research Centerو Ferdowsi university campus, Azadi square
Mashhad Iran (Islamic Republic of) +98 51 3800 2463 darchinime861@mums.ac.ir Ferdowsi university campus, College of medicine scientific Dr Anahita Alizadeh-Ghamsari
Imam Reza Hospital, Medical Toxicology Research Center (MTRC)
Mashhad Iran (Islamic Republic of) +98 51 3880 2463 alizadehan@mums.ac.ir Medical toxicology research center, Imam Reza hospital, Imam Reza square, Mashhad Iran (Islamic Republic of) Inclusion criteria: filling the written informed consent by both parents; born at gestational age of ≥37 weeks; aged >24 hours (between 1-5 days); has 5 minutes APGAR score of ≥ 7 Exclusion criteria: Medically instable infants; those who had received sedatives or analgesics in the past 48 hours; infants who had received naloxone in the previous 24 hours; preterm and Low Birth Weight (LBW) infants; Those who had been fed in the past 30 minutes 1 day 5 days Both R52.0 pain, not elsewhere classified Placebo Treatment - Other Treatment - Other 2 ml of sterile water as placebo will be prepared and syringed in anterior part of the tongue 2 minutes before sampling 2 ml sucrose 25% will be prepared in advance and syringed in anterior part of tongue 2 minutes before sampling Infants will be breastfed in kangaroo care. Breastfeeding will be started 2 minutes before sampling and continue during the sampling. Infants are dressed, thus there is no skin to skin contact with mother. Mothers are not allowed to speak with their babies nor swaddle them. Heart rate. Timepoint: each minute until 3 minutes after sampling. Method of measurement: cardiac monitoring. Blood pressure. Timepoint: each minute until 3 minutes after sampling. Method of measurement: cardiac monitoring. Capillary oxygen saturation level. Timepoint: each minute until 3 minutes after sampling. Method of measurement: cardiac monitoring. Pain alleviating. Timepoint: each minute until 3 minutes after sampling. Method of measurement: neonatal infants pain scale score (NIPS). Vice-chancellor for research- Mashhad University of Medical Sciences, Mashhad, Iran Approved 2014-10-19 Ethics committee of Mashhad University of Medical Sciences Ethics committee, central building of Mashhad University of Medical Sciences (Ghorshi building), Daneshgah avenue, Mashhad, Iran Mashhad Iran (Islamic Republic of)