Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial

Abstract

Neonatal circumcision is one of the most frequently performed procedures in male infants; it is also particularly painful. In a previous trial, we showed that the combination of Eutectic Mixture of Local Anesthetics (EMLA)+Sucrose+Ring Block (RB) was significantly effective in reducing pain during circumcision. In this study, we added music as an adjunct aiming to further reduce the pain scores. This was a double-blinded randomized controlled trial comparing EMLA+Sucrose+RB (Control) to EMLA+Sucrose+RB+Music (Intervention). The trial setting was the normal nursery of a university teaching hospital. One hundred and three healthy newborn males were randomized to each of the intervention and control groups. Babies were videotaped (face and torso) during the procedure for assessment of pain by two blinded and independent reviewers. The primary outcome measure was the NIPS score; secondary outcomes included heart rate, oxygen saturation and crying time. The NIPS score of the intervention group (EMLA+Sucrose+RB+Music [2.6±1.6]) was significantly higher than that of the control group (EMLA+sucrose+RB [1.4±0.9]) (p=0.00). Inter-rater reliability was high (κ .89). The intervention group registered significantly higher mean heart rate (142 bpm) and increased mean crying time (5.44s) compared to the control group (135 bpm and 1.63s, respectively) (p=0.01) and (p=0.00). No adverse events were noted. Delivery music medicine by playing it from an iPad in the procedure room did not reduce pain during circumcision. There is overwhelming evidence in the literature describing the effectiveness of music on pain management especially in the NICU. However, our results did not align with the general trend; not only did music medicine fail to enhance analgesia but it might have had the opposite effect, further agitating the infants, as indicated by the significantly increased heart rate, crying time and NIPS scores of the participants in the intervention group. Limitations of our study include the fact that this is a single center study and the method of delivering music via iPads instead of noise-canceling headphone. Our results showed that music, delivered in this manner, may have increased agitation. We affirm the fact that the combination of EMLA+Sucrose+RB is highly effective for managing pain during circumcision and further reduction of already low scores might not be possible. Registry Name: ClinicalTrials.gov; Registration number: NCT04252313; link: https://clinicaltrials.gov/ct2/show/NCT04252313.