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Clinical Trial
. 2017 Mar 30;34(2):301-307.
doi: 10.20960/nh.163.

[Breastfeeding for acute pain control on infants: a randomized controlled trial]

[Article in Spanish]
Affiliations
Clinical Trial

[Breastfeeding for acute pain control on infants: a randomized controlled trial]

[Article in Spanish]
Jessie Nallely Zurita-Cruz et al. Nutr Hosp. .

Abstract

Objective: To determine the effectiveness of breastfeeding (BF) for the management in acute pain after vaccination in infants under 6 months of age when compared to the milk substitute (MS) and not to apply any maneuver. Methods: A controlled, single-blind phase III clinical trial was conducted on infants under 6 months old to evaluate the effectiveness of BF in acute pain by vaccination. Divided in 3 groups: BF, milk substitutes (MS), and without applying any analgesic maneuver (control). Pain was measured by crying time and pediatric pain scale. Statistical analysis was performed using the Kruskal Wallis and Mann-Whitney U for quantitative variables. For qualitative data, Chi2 was applied Kaplan Meier was used to analyze the total time crying. Results: A total of 144 patients were recruited, divided in groups of 48 patients. The group of BF had fewer crying time (p = 0.007) and pain rating at 90 (p = 0.006) and 120 (p = 0.003) seconds compared with other groups. There was no significant difference in the crying time (p = 0.396) and the pain scale between the group receiving MR and control. Conclusions: Breastfeeding is effective in management of acute pain by vaccination in infants under six months of age compared to milk substitute and control.

Objetivo: determinar la eficacia de la lactancia materna (LM) para el manejo del dolor agudo después de la vacunación en lactantes menores de 6 meses al compararse con el sucedáneo de la leche (SL) y no aplicar ninguna maniobra. Métodos: se realizó un ensayo clínico controlado aleatorizado, ciego simple en fase III en lactantes menores de 6 meses de edad. Se incluyeron 3 grupos: LM, SL y sin aplicar analgesia (control). El dolor se midió a través del tiempo de llanto y una escala de dolor pediátrico. En el análisis estadístico se utilizaron las pruebas de Kruskal Wallis y U de Mann Whitney para variables cuantitativas y para variables cualitativas se aplicó la prueba de Chi2. Se utilizó Kaplan Meier para analizar el tiempo de llanto total. Resultados: se analizaron un total de 144 pacientes, 48 por grupos. El grupo de LM tuvo menor tiempo de llanto (p = 0,007) y menor calificación de dolor a los 90 (p = 0,006) y 120 (p = 0,003) segundos comparado con los otros 2 grupos. Mientras que entre el grupo SL y el grupo control no hubo diferencia significativa en la duración del llanto ni la escala de dolor. Conclusiones: la lactancia materna es efectiva para el manejo del dolor agudo después de la vacunación en lactantes menores de 6 meses de edad en comparación al sucedáneo de leche y no aplicar analgesia.

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