This trial aimed to evaluate the efficacy of topical lidocaine gel combined with behavioural distraction techniques for pain reduction during peripheral venous catheterization in paediatric patients. The effect of the intervention was compared with that of the present general standard of care, and the goal was to demonstrate superiority over the standard of care. The allocation ratio was 1:1 for the intervention group and the control group.

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. The intervention group received a standardized application of 2% lidocaine gel centred at the puncture site. In the control group, children received preferred distraction measures on the basis of individual preferences, and standard venous catheterization was performed. The primary outcome was pain intensity.

The secondary outcome measures included the one-time success rate of catheterization, the satisfaction of their companies, and local or systemic adverse reactions.

The randomization sequence was computer-generated via a simple randomization procedure based on a random number table, with an equal allocation ratio (1:1). Upon enrollment, each participant was assigned a unique random number generated via Microsoft Excel® software. The researcher assistants did not know these random numbers and put all the numbers into envelopes. The envelope was not opened until the intervention was implemented. Owing to the nature of the intervention, the blinding of operating nurses, children and companions after assignment was not feasible, and the researchers who performed the outcome assessment and data analysis were not blinded.

The inclusion criteria were as follows: (a) aged 2 months to 14 years; (b) provided informed consent from the guardian; and (c) were children with no pain. The exclusion criteria were children with skin diseases or unclear veins or known or suspected allergies to local anaesthetic drugs. The included children were randomly assigned by a research assistant.

The research team consisted of 2 head nurses, 3 operational implementers and 1 research assistant. The study design and the whole implementation stage were controlled and supervised by 2 head nurses. The whole implementation stage was performed by three nurses with 10 years or more of working experience in pediatrics, a professional qualification certificate for intravenous therapy nurses, and a standardized training operation process. The randomization and data collection of the studies were completed by a research assistant.

Twenty-one 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 intensity significantly differed 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.

The combined use of lidocaine gel and preferred distraction techniques has significant efficacy in alleviating venipuncture-induced pain in pediatric populations; however, it does not increase first-attempt success rates or procedural satisfaction.