Abstract
SummaryBackgroundIncreasing numbers of neonates are undergoing painful procedures in low-income and middle-income countries, with adequate analgesia seldom used. In collaboration with a multi-disciplinary team in Kenya, we aimed to establish the first evidence-based guidelines for the management of routine procedure-related neonatal pain that consider low-resource hospital settings.MethodsWe did a systematic review by searching MEDLINE, Embase, CINAHL, and CENTRAL databases for studies published from Jan 1, 1953, to March 31, 2019. We included data from randomised controlled trials using heart rate, oxygen saturation (SpO2), premature infant pain profile (PIPP) score, neonatal infant pain scale (NIPS) score, neonatal facial coding system score, and douleur aiguë du nouveau-né scale score as pain outcome measures. We excluded studies in which neonates were undergoing circumcision or were intubated, studies from which data were unextractable, or when pain was scored by non-trained individuals. We did a narrative synthesis of all studies, and meta-analysis when data were available from multiple studies comparing the same analgesics and controls and using the same outcome measures. 17 Kenyan health-care professionals formed our clinical guideline development panel, and we used the Grading of Recommendations, Assessment, Development and Evaluation framework and the panel's knowledge of the local health-care context to guide the guideline development process. This study is registered with PROSPERO, CRD42019126620.FindingsOf 2782 studies assessed for eligibility, data from 149 (5%) were analysed, with 80 (3%) of these further contributing to our meta-analysis. We found a high level of certainty for the superiority of breastfeeding over placebo or no intervention (standardised mean differences [SMDs] were −1·40 [95% CI −1·96 to −0·84] in PIPP score and −2·20 [–2·91 to −1·48] in NIPS score), and the superiority of oral sugar solutions over placebo or no intervention (SMDs were −0·38 [–0·61 to −0·16] in heart rate and 0·23 [0·04 to 0·42] in SpO2). We found a moderate level of certainty for the superiority for expressed breastmilk over placebo or no intervention (SMDs were −0·46 [95% CI −0·87 to −0·05] in heart rate and 0·48 [0·20 to 0·75] in SpO2). Therefore, the panel recommended that breastfeeding should be given as first-line analgesic treatment, initiated at least 2 min pre-procedure. Given contextual factors, for neonates who are unable to breastfeed, 1–2 mL of expressed breastmilk should be given as first-line analgesic, or 1–2 mL of oral sugar (≥10% concentration) as second-line analgesic. The panel also recommended parental presence during procedures with adjunctive provision of skin-to-skin care, or non-nutritive sucking when possible.InterpretationWe have generated Kenya's first neonatal analgesic guidelines for routine procedures, which have been adopted by the Kenyan Ministry of Health, and have shown a framework for clinical guideline development that is applicable to other low-income and middle-income health-care settings.FundingWellcome Trust Research Programme, and the Africa-Oxford Initiative.
Highlights
Global efforts to reduce neonatal mortality have led to substantial increases in the numbers of neonates being treated as inpatients
PICO question comparisons that were prioritised by the Neonatal Pain Guideline Group (NPGG) in their discussions were those involving breastfeeding, oral sugar, expressed breastmilk, skin-toskin care, and non-nutritive sucking.[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122]
GRADE summaries for other PICO questions considered by the NPGG but not discussed here due to the NPGG deprioritising them on the basis of local feasibility and analgesic efficacy are 5906 records identified through database searching
Summary
Global efforts to reduce neonatal mortality have led to substantial increases in the numbers of neonates being treated as inpatients. Observational studies have shown that neonates often undergo more than a dozen painful procedures per day while on neonatal intensive care units.[1] untreated pain is associated with significant neurophysiological and developmental consequences.[2] Ethics boards, the neonatology community, and parents have emphasised the need to minimise pain,[3] but the paucity of clear guidelines, busy clinical environments, and difficulty in reliably measuring pain in neonates have resulted in an ongoing and substantial burden of unaddressed neonatal pain.[4]. A national cross-sectional survey done in Kenya found that over a single day, no neonate received analgesia for any of the 404 routine procedures that were done.[5] Untreated neonatal pain, repre sents a huge global source of short-term and potentially www.thelancet.com/child-adolescent Vol 4 October 2020
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