Comparative efficacy of pharmacological and non-pharmacological interventions for mitigating pain and anxiety associated with venipuncture: a randomised controlled trial

Background Venipuncture is one of the most commonly performed medical procedures in paediatric care, but it can also be one of the most painful and distressing experiences for patients. Finding effective strategies to manage pain and fear associated with venipuncture is crucial for improving the paediatric patient experience and promoting positive health outcomes. This study aimed to evaluate the efficacy of a combined approach using a topical analgesic cream (TKTX cream) and a distraction technique (Trace Image and Colouring for Kids-Book, TICK-B) in reducing pain intensity and fear levels in children undergoing venipuncture procedures. Methods We conducted this randomised controlled trial among 176 children aged 6–12 years undergoing venipuncture. Participants were randomly assigned to four groups: TICK-B, TKTX cream, TICK-B+TKTX cream and a control group. Pain and fear were measured using the Wong-Baker FACES Pain Rating Scale and Children’s Fear Scale. The study was carried out from 20 February 2024 to 1 June 2024 at the emergency unit of Heevi paediatric teaching hospital in the Kurdistan region of Iraq. In the intervention groups, TICK-B was applied for 2–3 min before needle insertion, and TKTX cream was applied 20 min before the venipuncture procedure. All outcome measures were evaluated 2–3 min after the completion of the venipuncture procedure. Results The combined TICK-B (colouring book) and TKTX cream (topical anaesthetic) intervention was the most effective in reducing both pain intensity (mean score 2.80 vs 7.24 in the control, p<0.001) and fear levels (mean score 0.93 vs 2.83 in the control, p<0.001) during and after venipuncture procedures compared with individual interventions and control. Conclusions The combined TICK-B distraction and TKTX cream topical anaesthetic intervention was the most effective in reducing pain intensity and fear during and after venipuncture in children, providing a practical strategy for healthcare providers to optimise needle procedure management. Trial registration number [NCT06326125][1]. Data are available upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06326125&atom=%2Fbmjpo%2F8%2F1%2Fe002881.atom