Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial.

BACKGROUND: Venipuncture is a routine nursing procedure in the pediatric ward for blood collection and transfusion. However, this procedure can cause severe pain and distress if not adequately managed. METHODS: Children aged 3-16 years old were randomized into three groups: EMLA group, distraction group, and combined group. The primary outcome was children's self-reported pain scored using the Wong-Baker FACES® Pain Rating Scale. The parents-reported and observer-reported pain were scored using the Revised Face, Legs, Activity, Cry and Consolability Scale, and children's salivary cortisol levels, heart rate, percutaneous oxygen saturation, venipuncture duration and retaining time of IV cannulas were the secondary outcomes. RESULTS: A total of 299 children (167 male, 55.8%, median age 8.5) were enrolled: EMLA group (n = 103), distraction group(n = 96) and combined group(n = 100). There was no statistical difference in self-reported pain (P = 0.051), parent-reported pain (P = 0.072), and observer-reported pain (P = 0.906) among the three groups. All three interventions can decrease children's pain during IV cannulations. Additionally, the distraction group's salivary cortisol levels were lower than the combined group(P = 0.013). Furthermore, no significant difference was observed in the heart rate(P = 0.844), percutaneous oxygen saturation (P = 0.438), venipuncture duration (p = 0.440) and retaining time of IV cannulas (p = 0.843) among the three groups. CONCLUSIONS: All three groups responded with slight pain during the peripheral venipuncture procedure. Therefore, medical workers in pediatric settings can use the interventions appropriate for their medical resources and availability while involving parents and children's preferences whenever possible. TRIAL REGISTRATION: This trial was registered on https://register. CLINICALTRIALS: gov/ (Gov.ID NCT04275336).