Combined use of EMLA cream and Buzzy for peripheral intravenous cannulation in children: a randomized controlled trial.

AIM: Preventing pain and distress during peripheral intravenous cannulation in children is essential to avoid long-term anxiety or needle phobia. This study evaluated whether combining EMLA cream with the Buzzy device is more effective than EMLA alone in reducing procedural distress and pain. MATERIALS AND METHODS: We conducted a randomized controlled trial in two tertiary children's hospitals in Italy (March-October 2023). Children aged 4-12 years requiring intravenous cannulation were randomized to receive either EMLA alone or EMLA plus Buzzy. The primary outcome was distress, assessed by parents using the Children's Emotional Manifestation Scale (CEMS). Secondary outcomes included pain measured with the Faces Pain Scale-Revised (FPS-R) by children, parents, and healthcare operators, operator-rated distress, first-attempt success, and adverse events. Analyses followed an intention-to-treat basis. RESULTS: Ninety-four children (median age 8 years) were enrolled: 47 in the EMLA plus Buzzy group and 47 in the EMLA alone group. Parent-rated distress was significantly lower with EMLA plus Buzzy (median CEMS 6, IQR 5-7) than with EMLA alone (9, IQR 7-12; p = 0.001). Pain scores and first-attempt success rates were similar. No severe adverse events occurred. CONCLUSION: Combining EMLA and Buzzy significantly reduced procedural distress perceived by parents without affecting pain scores.