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| Author(s): |
Mariana Bueno
Total Authors: 1
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| Document type: | Doctoral Thesis |
| Press: | São Paulo. |
| Institution: | Universidade de São Paulo (USP). Escola de Enfermagem (EE/SBD) |
| Defense date: | 2011-02-22 |
| Examining board members: |
Amélia Fumiko Kimura;
Vera Lúcia Jornada Krebs;
Adriana Moraes Leite;
Lisabelle Mariano Rossato;
Bonita Jean Stevens
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| Advisor: | Amélia Fumiko Kimura |
| Abstract | |
Background: Late preterm neonates undergo repeated heel lancing during their first hours of life due to capillary blood glucose monitoring. Heel lancing is a painful procedure however pain relief strategies are rarely implemented prior to the lances. Aim: To compare the efficacy of expressed breast milk and 25% glucose on pain scores of late preterm infants during heel lancing. Methods: This is a noninferiority randomized controlled trial, conducted at the Berçário Anexo à Maternidade do Instituto da Criança da Faculdade de Medicina da Universidade de São Paulo (BAM-ICrFMUSP) between August 2009 and May 2010. A total of 113 newborns were randomized: 56 comprised the experimental group (EG) and 57, the control group (CG). Two minutes before heel lancing, EG received 2mL of expressed breast milk (EBM) orally and CG received 2mL of 25% glucose orally. The Premature Infant Pain Profile (PIPP) score was the primary outcome and it was assessed within 180 seconds after lancing (T30, T60, T90, T120, T150 and T180). Secondary outcomes were: grimacing (brow bulging, eye squeezing, nasolabial furrowing), changes in heart rate (HR), and oxygen saturation (SpO2), crying, and adverse events. The research project was approved by the local ethics committee and was registered at the Australian and New Zealand Clinical Trials Registry. Results: Due to absence or insufficient volume of EBM, 25 neonates did not receive the intervention, but were included in the intention to treat analysis. The groups were similar with respect to type of delivery, Apgar score at 5 minutes, sex, gestational age, postnatal age in hours, interval between last feeding and data collection, and capillary blood glucose. There were statistically significant differences amongst the groups regarding birth weight (p=0.013) and weight at the time of the procedure (p=0.017). The analysis of variance (ANOVA) indicated lower pain scores in the CG: there was a significant difference between the interventions, regardless time (p<0.001), and main effect of the time, independent of the intervention (p<0.001). The CG had a higher frequency of PIPP scores indicative of minimal pain or absence of pain (p= 0.002 and p=0.003 on intention to treat analysis). Lower mean percentage of time of brow bulging occurrence, eye squeezing and nasolabial furrowing was observed for CG in comparison to EG. There was a statistically significant difference on brow bulging occurrence amongst the groups (p<0.001) and over the time (p<0.001). ANOVA indicated interaction between interventions and time (p=0.001) for eye squeezing. Infants who received breast milk demonstrated significant reduction on eye squeezing occurrence when comparing T30 and the remaining intervals (p_0.0014). In the CG, a significant reduction on eye squeezing were observed when comparing T30 to T90 (p=0.0155), to T150 (p=0.0261) and to T180 (p=0.0122). As for nasolabial furrowing, there was interaction (p<0.001). Statistically significant differences between the T30 and all other periods (p<0.001) were observed for EG, except when comparing T30 and T60. For neonates who received glucose, there were significant reductions in nasolabial furrowing occurrence between T30 and T90 (p=0.022) and T30 and T180 (p=0.0175). There was interaction in the evaluation of HR (p=0.027). No statistically significant differences were observed in HR over time for EG (p=0.563) and CG (p=0.955). Regarding SpO2, there were significant differences between intervention groups (p=0.004) and over the time (p=0.017). Of the infants who received EBM, 33 cried after lancing; in the CG, 19 neonates cried (p=0.001 and p=0.001 on intention to treat analysis). Longer mean percentage of duration of crying was observed in EG (p=0.014). Adverse events were benign and self-limited and there was no statistically significant difference among the groups (p=0.736 and p=0.637 on intention to treat analysis). Noninferiority margin was established in 2 points and the hypothesis test indicated a 95% confidence interval 1.507 to 4.483. Conclusion: The hypothesis test of noninferiority of EBM as compared to 25% glucose solution on reducing PIPP score in late preterm neonates undergoing heel lancing in was inconclusive. (AU) | |