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      Ethics of conducting the study “Oral 24% sucrose associated with nonnutritive sucking for pain control in healthy term newborns receiving venipuncture beyond the first week of life” [Response to Letter]

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          Abstract

          Dear editor We are glad to respond to the concerns raised by Harrison and Bueno regarding our manuscript. Some mistakes and misunderstanding in the original letter need to be addressed. The surname of the first author is De Bernardo and not Bernardo. In our paper, 66 healthy newborns with a mean of 22 days of life were enrolled. This was the first novelty in the study design. Secondly, the patients were newborns discharged from hospital and readmitted for routine controls in the neonatal ward. The setting of the study was thus quite different from neonatal intensive-care units or rooming-in inpatients in the first days of life. The study aimed to test the effectiveness of sweet solutions associated with nonnutritive sucking in healthy and unhospitalized newborns. Newborns received oral 24% sucrose or 10% glucose before and during venipuncture, starting with a pacifier for nonnutritive sucking in both groups. The authors did not limit their analysis to effectiveness of the sweet solutions as nonpharmacological treatment, but they studied the efficacy of the sweet solutions in association with nonnutritive sucking in the neonatal period, during the third week of life, and in a new setting. For this reason, the study complied with the principle of equipoise. Our research team have already performed several studies on neonatal pain.1–8 We are sorry that we did not cite the work of Harrison and Bueno, but the list of references reported in the manuscript was adequate for the aim of the study. In a meta-analysis, Harrison et al considered eligible 62 trials that included term and/or preterm infants in the neonatal period, receiving sucrose, glucose, or other sweet solutions orally compared with no treatment, water, pacifier, swaddling/positioning, skin-to-skin care, formula feeding, expressed breast milk, breastfeeding, sensorial saturation, or topical anesthetics.9 Furthermore, this meta-analysis focused only on crying time and composite infant pain-intensity scores to evaluate the effectiveness of nonpharmacological treatments. Our study aimed to investigate the use of sweet solutions in association with nonnutritive sucking in the neonatal period (0-29 days) beyond the first 2 weeks of life in healthy unhospitalized newborns who returned to the clinic for checkup and had venipuncture requested.10 Parents were fully informed about the aims of the study, and they were also able to choose to provide their newborn breastfeeding, nonnutritive sucking, or sweet solutions alone during venipuncture. To the best of our knowledge, this is the first study in the literature to investigate the efficacy of 24% sucrose as an analgesic in healthy unhospitalized newborns in the third week of life. This research reduces the gap in health assistance during the neonatal period. A pilot study can be also a way to implement nonpharmacological treatment to control pain in newborns in settings other than intensive-care units. Despite evidence existing on the efficacy of sweet solutions since the 2000s, it is still not routine analgesic procedure in neonatal care. In conclusion, the study contributes to reducing the gap between theory and clinical practice and paves the way to encourage and implement the best clinical practice for newborns.

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          Most cited references 9

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          Sensorial saturation for neonatal analgesia.

          Sensorial saturation (SS) is a procedure in which touch, massage, taste, voice, smell, and sight compete with pain, producing almost complete analgesia during heel prick in neonates. SS is an apparently complex maneuvre, but when correctly explained it is easily learnt. In the present paper, we studied its feasibility, assessing whether a long training is really needed to achieve good results.
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            Effect of multisensory stimulation on analgesia in term neonates: a randomized controlled trial.

            Many attempts have been made to obtain safe and effective analgesia in newborns. Oral glucose-water has been found to have analgesic properties in neonates. We investigated whether other sensory stimulation added to oral glucose provided more effective analgesia than oral glucose alone. In a randomized prospective double-blind trial, we studied 120 term newborns during heel prick. The babies were divided randomly into six groups of 20, and each group was treated with a different procedure during heel prick: A) control; B) 1 mL 33% oral glucose given 2 min before the heel prick; C) sucking; D) 1 mL 33% oral glucose plus sucking; E) multisensory stimulation including 1 mL 33% oral glucose (sensorial saturation); F) multisensory stimulation without oral glucose. Sensorial saturation consisted in massage, voice, eye contact, and perfume smelling during heel prick. Each heel prick was filmed and assigned a point score according to the Douleur Aiguë du Nouveau-né (DAN) neonatal acute pain scale. Camera recording began 30 s before the heel prick, so it was impossible for the scorers to distinguish procedure A (control) from B (glucose given 2 min before), C (sucking water) from D (sucking glucose), and E (multisensory stimulation and glucose) from F (multisensory stimulation and water) from the video. Procedure E (multisensory stimulation and glucose) was found to be the most effective procedure, and the analgesia was even more effective than that produced by procedure D (sucking glucose). We conclude that sensorial saturation is an effective analgesic technique that potentiates the analgesic effect of oral sugar. It can be used for minor painful procedures on newborns.
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              Sweet Solutions to Reduce Procedural Pain in Neonates: A Meta-analysis

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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                JPR
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                28 June 2019
                2019
                : 12
                : 1915-1916
                Affiliations
                [1 ] Department of Emergency, NICU, AORN Santobono-Pausilipon , Naples, Italy
                [2 ] Department of Molecular and Developmental Medicine, University of Siena , Siena, Italy
                [3 ] Faculty of Medicine, Federico II University , Naples, Italy
                Author notes
                Correspondence: Serafina PerroneDepartment of Molecular and Developmental Medicine, University of Siena , 36 Viale Bracci, Siena53100, ItalyTel +39 057 758 6542Fax +39 057 758 6182Email saraspv@ 123456yahoo.it
                Article
                217275
                10.2147/JPR.S217275
                6607974
                © 2019 De Bernardo et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                References: 10, Pages: 2
                Categories
                Response to Letter

                Anesthesiology & Pain management

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