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

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 PainAway® and or standard hepatitis B intramuscular injection. The pain response was assessed using Douleur Aiquedu Noureanu-né(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 PainAway® can reduce the pain secondary to hepatitis B intramuscular injection on term neonates.

Keywords

• PainAway®, intramuscular injection, term neonates