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Oral Sucrose and “Facilitated Tucking” for Repeated Pain Relief in Preterms: a Randomized Controlled Trial

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Oral Sucrose and “Facilitated Tucking” for Repeated Pain Relief in Preterms: a Randomized Controlled Trial ARTICLE Oral Sucrose and “Facilitated Tucking” for Repeated Pain Relief in Preterms: A Randomized Controlled Trial AUTHORS: Eva L. Cignacco, PhD, RM,a Gila Sellam, MSN, WHAT’S KNOWN ON THIS SUBJECT: Preterm infants are exposed RN,a Lillian Stoffel, BSN, RN,b Roland Gerull, MD,b Mathias to inadequately managed painful procedures during their NICU Nelle, MD,b Kanwaljeet J. S. Anand, Prof, MBBS, DPhil,c and stay, which can lead to altered pain responses. Nonpharmacologic Sandra Engberg, Prof, PhD, CRNP, FAANa,d approaches are established for the treatment of single painful aInstitute of Nursing Science, University of Basel, Basel, procedures, but evidence for their effectiveness across time is Switzerland; bDivision of Neonatology, Children’s Hospital, lacking. University Hospital Bern, Bern, Switzerland; cPediatric Critical Care Medicine, Le Bonheur Children’s Hospital, University of Tennessee Health Science Center, Memphis, Tennessee; and WHAT THIS STUDY ADDS: Oral sucrose with or without the added dSchool of Nursing, University of Pittsburgh, Pittsburgh, technique of facilitated tucking has a pain-relieving effect even in Pennsylvania extremely premature infants undergoing repeated pain KEY WORDS exposures; facilitated tucking alone seems to be less effective for infant premature, pain, analgesia, nonpharmacologic pain relief, repeated pain exposures over time. sucrose, facilitated tucking ABBREVIATIONS BPSN—Bernese Pain Scale for Neonates B-BPSN—behavioral Bernese Pain Scale for Neonates score FT—facilitated tucking GA—gestational age abstract NPI—nonpharmacologic intervention P-BPSN—physiological Bernese Pain Scale for Neonates score OBJECTIVES: To test the comparative effectiveness of 2 nonpharmaco- T-BPSN—total Bernese Pain Scale for Neonates score logic pain-relieving interventions administered alone or in combination Dr Cignacco, primary investigator, was responsible for across time for repeated heel sticks in preterm infants. development of study design and organization of the study, data METHODS: A multicenter randomized controlled trial in 3 NICUs in collection, supervision of doctoral student in all the empirical steps, and manuscript draft and revision. Ms Sellam, doctoral Switzerland compared the effectiveness of oral sucrose, facilitated student, was responsible for data collection, data entry and tucking (FT), and a combination of both interventions in preterm in- quality check, data analysis, and manuscript draft and revision. fants between 24 and 32 weeks of gestation. Data were collected during Ms Stoffel and Dr Gerull were responsible for data collection, fi manuscript revision, and critical review. Dr Nelle, coinvestigator, the rst 14 days of their NICU stay. Three phases (baseline, heel stick, was responsible for manuscript revision and critical review. Dr recovery) of 5 heel stick procedures were videotaped for each infant. Anand, research funding advisor, was responsible for Four independent experienced nurses blinded to the heel stick phase development of the study design, manuscript revision, and rated 1055 video sequences presented in random order by using the critical review. Dr Engberg, methodological advisor, was responsible for development of the study design, reviews of data Bernese Pain Scale for Neonates, a validated pain tool. analysis, manuscript revision, and critical review. RESULTS: Seventy-one infants were included in the study. Interrater www.pediatrics.org/cgi/doi/10.1542/peds.2011-1879 reliability was high for the total Bernese Pain Scale for Neonates score doi:10.1542/peds.2011-1879 (Cronbach’s a:0.90–0.95). FT alone was significantly less effective in Accepted for publication Sep 28, 2011 relieving repeated procedural pain (P , .002) than sucrose (0.2 mL/kg). Address correspondence to Eva L. Cignacco, PhD, RM, FT in combination with sucrose seemed to have added value in the Bernoullistrasse 28, CH-4056 Basel, Switzerland. E-mail: eva. recovery phase with lower pain scores (P = .003) compared with both [email protected] the single-treatment groups. There were no significant differences in pain PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). responses across gestational ages. Copyright © 2012 by the American Academy of Pediatrics CONCLUSIONS: Sucrose with and without FT had pain-relieving effects FINANCIAL DISCLOSURE: The authors have indicated they have , no financial relationships relevant to this article to disclose. even in preterm infants of 32 weeks of gestation having repeated pain exposures. These interventions remained effective during repeated heel sticks across time. FT was not as effective and cannot be recommended as a nonpharmacologic pain relief intervention for repeated pain exposure. Pediatrics 2012;129:1–10 PEDIATRICS Volume 129, Number 2, February 2012 1 Downloaded from www.aappublications.org/news by guest on October 2, 2021 The survival of preterm infants is de- infant with support and the chance to intraventricularhemorrhage(gradesIII pendentonhighlysophisticatedintensive control his or her own body.16 Several and IV), had life-threatening malforma- care, associated with an exceedingly high studies reported that FT stabilizes be- tions or disorders affecting brain circu- number of painful procedures.1 This is havioral and physiologic states during lation or the cardiovascular system, had particularly true for infants with ex- single heel sticks and endotracheal undergone a surgical procedure, had tremely low gestational ages (GAs) who suctioning, reducing the infant’s stress apH,7.00, or had any problem that also receive less analgesia.2–5 in coping with pain.16,27–31 could impair pain expression. Repeated pain exposures during criti- Althoughcurrentevidencesupportsthe cal windows of central nervous system effectiveness of NPIs for a single painful Sample Size Calculation development6,7 are associated with procedure, there is little research ex- By using sucrose only, we performed permanent changes in peripheral, spi- amining their effectiveness across re- a feasibility study to calculate a pre- nal, and supraspinal pain processing; peated painful procedures. To date, few liminary power analysis.39 We formu- neuroendocrine function; and neuro- studies have evaluated the effective- lated our calculations based on the logic development. These changes can ness of sucrose over time,32–36 and assumptions that sucrose and FTwould be manifested by alterations in pain none have evaluated FT across time. have equivalent effects that would thresholds, stress responses, cogni- The combination of 2 NPIs (eg, oral sustain over time. According to this tive function, behavioral disorders, sucrose and FT) may have additive analysis, a group size of n = 24 for each and long-term disabilities.7,8 Despite effects by stimulating infants in a multi- intervention group (n = 72 total sample this knowledge, many painful proce- sensorial way to cope with the painful size) provided adequate power to detect dures in NICUs are performed without experience.18,37,38 a pain reduction of 33% for the combi- pharmacologic or nonpharmacologic This study compared the impact of nation group relative to the 2 single in- analgesia.1–3,9 Disadvantages of phar- sucrose and FT alone and in combina- tervention groups with a power of 80%. macologic analgesia include side effects, tion on pain reactivity across multiple questionable efficacy, and possible neg- painful procedures. Randomized groups Data Collection and Management ative impact on neonatal outcomes.10–12 received oral sucrose, FT, and a combi- Data were collected during 5 noncon- As an alternative approach, nonpharma- nation of both strategies to evaluate secutive routine heel sticks (T1–T5) be- cologic interventions (NPIs) are recom- possible additive effects. The primary tween postnatal days 2 and 16, with the mended for pain management.13–15 outcome was pain response measured first heel stick performed no later than NPIs (eg, oral sucrose, breastfeeding, by the Bernese Pain Scale for Neonates day 4. For other painful procedures in- non-nutritive sucking, facilitated tuck- (BPSN) total and component scores. The cluding heel sticks where data were ing [FT], kangaroo care, swaddling) secondary outcome was the impact of not being collected, the infants were effectively reduce pain for minor to gestationalgroup(240/7to276/7and28 provided with sucrose 20%, which moderately painful procedures.15–17 0/7 to 32 0/7 gestational weeks) on the was the standard of care in all partici- They promote self-regulation of the infant effectiveness of these interventions. pating NICUs. Because the timing of and provide oro-tactile, oro-gustatory, blood sampling was determined by and tactile stimulation, capable of re- clinical considerations, there were no METHODS ducing infants’ pain responses during fixed time points for data collection. most painful procedures.15,18–21 Sucrose Setting and Sample Demographic data were collected from is recommended extensively for pain This randomized controlled trial was medical records. relief in preterm infants22–24 and has carried out in NICUs of 3 university Data collection occurred during (1) shown to be highly effective and safe for hospitals in Switzerland from January baseline (before any manipulation), (2) single procedures by Stevens et al.17 12 to December 31, 2009. Infants ad- heel stick (skin preparation, heel stick, Sweet taste solutions seem to trigger mitted to the NICU during this period and hemostasis after blood was drawn), endogenous opioid and nonopioid path- were assessed for eligibility
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