Specific objectives: This study aimed to explore the efficacy of lidocaine gel combined with preferred distraction techniques for alleviating venipuncture pain in pediatric patients. Trial design and framework: This prospective, parallel group, randomized controlled trial demonstrated superior efficacy compared with standard care. Methods: We recruited children aged 2 months to 14 years during February, 2025, who needed venipuncture before surgery in the pediatric surgery department of a tertiary hospital in Chengdu, China. In the control group, children received preferred distraction measures, and standard venous catheterization was performed. Based on the control group, the intervention group received a standardized application of 2% lidocaine gel centred at the puncture site. The primary outcome was pain scores and severity. The randomization sequence was computer-generated on a random number table. Results: Forty-two participants were randomized to each group. The pain score differed significantly between the intervention and control groups (median: 3 [0–9] vs 8 [0–10], p=0.029). The pain severity did not significantly differ between the intervention group and the control group (c2=4.756, p=0.091). Children with mild pain accounted for 28.6% and 16.7% of the children in the intervention group and control group, respectively. The success rate at the first attempt at venipuncture and the satisfaction of companions were not significantly different between the two groups. Conclusions The combined use of lidocaine gel and preferred distraction techniques has significant efficacy in alleviating venipuncture-induced pain score in pediatric populations; however, it does not increase first-attempt success rates or procedural satisfaction. Trial registry and identification number: Registered at the Chinese Clinical Trial Registry (ChiCTR) (ID: ChiCTR2500096620, Date of registration: 26 January 2025, URL: https://www.chictr.org.cn/index.html). Retrospectively registered.