Objective: A randomized controlled trial compared a reusable device combining cold and vibration to standard care for pediatric venous access pain relief.
Methods: Pediatric emergency department patients received either the cold vibration device placed 5 to 10 cm proximally throughout venipuncture or standard care control (primarily vapocoolant spray). Block randomization of patients with or without lidocaine cream already in place ensured equal allocation in both intervention groups. Pain was measured via self- and parent-report using the 0- to 10-point Faces Pain Scale-Revised and with coded videotaped observed behaviors. Venipuncture success, use of distraction, and access times were also assessed.
Results: Eighty-one 4- to 18-year-olds were randomized to the device (n = 41) or standard care (n = 40) (median age, 10.09 years; 95% confidence interval [95% CI], 8.91-10.89). Median patient-reported pain scores with the device were lower than with standard care (-2; 95% CI, -4 to 0), as were parent-assessed pain scores (-2; 95% CI, -4 to -2). Observed distress behaviors were more common with standard care (2; 95% CI, 1-3) than with the device (1; 95% CI, 0-2). Venipuncture success was more likely with the device (odds ratio, 3.05; 95% CI, 1.03-9.02). There were no device refusals.
Conclusions: The combination of cold and vibration decreased venipuncture pain significantly more than standard care without compromising procedural success. A device incorporating these elements could overcome the common barriers to needle procedure pain control.
Trial registration: ClinicalTrials.gov NCT00919100.