Effectiveness of PainAwayÂ® on hepatitis B intramuscular injection in term neonates: a randomized controlled trial

Susilawati Susilawati; Soetjiningsih Soetjiningsih; Bagus Ngurah Putu Arhana; Ida Bagus Subanada

doi:10.14238/pi50.4.2010.214-9

Susilawati Susilawati Department of Child Health, Medical School, Udayana University, Sanglah Hospital
Soetjiningsih Soetjiningsih Department of Child Health, Medical School, Udayana University, Sanglah Hospital
Bagus Ngurah Putu Arhana Department of Child Health, Medical School, Udayana University, Sanglah Hospital
Ida Bagus Subanada Department of Child Health, Medical School, Udayana University, Sanglah Hospital

DOI: https://doi.org/10.14238/pi50.4.2010.214-9

Keywords: PainAwayÂ®, intramuscular injection, term neonates

Abstract

Background Routine immunization injections are the most
common painful procedure in childhood and most of these
injections are administered in early life. Immunizations can cause
negative short- and long-term consequences for children. Children
who experience high levels of pain during an immunization
are more likely to have elevated distress level of subsequent
injections.
Objective To evaluate the effectiveness of pain away in reducing
pain associated with hepatitis B intramuscular injection in term
neonates.
Methods An open randomized controlled trial on healthy term
neonates was conducted between November 2009 and December
2009 at Sanglah Hospital in Denpasar, Bali. Subject were selected
randomized using six-blocked randomization. The samples
were divided into two groupsto either recieve intramuscular
hepatitis B injection using PainAwayÂ® and or standard hepatitis
B intramuscular injection. The pain response was assessed using
Douleur Aiquedu Noureanu-nÃ©(DAN) scale. Mann-Whitney test
was used to analyze the data. The confounding factor that may
have influenced the pain response was analyzed using multivariate
analysis (ANCOVA).
Results Out of 66 subject, DAN scale was significantly lower in
intervention group (median 5.0) compared to control (median 7.0)
with P < 0.0001. Multivariate analysis showed that the difference
in the intervention given was the only variable that influenced
the pain response (P < 0.0001).
Conclusion PainAwayÂ® can reduce the pain secondary to
hepatitis B intramuscular injection on term neonates.

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