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A Vibrating Cold Device to Reduce Pain in the Pediatric Emergency Department: A Randomized Clinical Trial
Debra Ann Potts1, Katherine Finn Davis2, Okan U Elci3
1From the Department of Nursing.
Insights
A vibrating cold device (VCD) and topical lidocaine (TL) equally reduced pain during IV catheter insertion in children. The VCD offers a faster alternative for pain management.
Area of Science:
- Pediatric Pain Management
- Medical Device Innovation
- Clinical Trials
Background:
- Intravenous (IV) catheter insertion can cause significant pain and distress in children.
- Effective analgesia is crucial to mitigate this distress.
- Current methods include topical anesthetics, but their onset can be slow.
Purpose of the Study:
- To compare the self-reported pain of IV catheter insertion in children using a vibrating cold device (VCD) versus standard 4% topical lidocaine cream (TL).
- To evaluate the noninferiority of VCD compared to TL in pain reduction.
- To assess secondary outcomes including anxiety, procedure success, and satisfaction.
Main Methods:
- A 2-arm randomized controlled noninferiority trial involving 4- to 18-year-olds requiring IV catheter insertion.
- Pain was measured using the Faces Pain Scale-Revised (FPS-R).
- Anxiety and observed pain were assessed using validated scales; caregiver and nurse satisfaction surveys were also completed.
Main Results:
- Both VCD and TL groups reported equivalent pain scores (median 2.0 cm on FPS-R).
- Observed pain scores were also similar between groups.
- IV procedure completion time was significantly shorter with VCD (3.0 minutes) compared to TL (40.5 minutes).
- No significant differences were found in anxiety, first-attempt success, or satisfaction.
Conclusions:
- A vibrating cold device (VCD) and topical lidocaine (TL) are equally effective in reducing pain and distress during pediatric IV catheter insertion.
- The VCD demonstrates a significant advantage with its rapid onset of action.
- The VCD is an acceptable and effective alternative for pain management in this setting.
Objective:
Pain of intravenous (IV) catheter insertion can be mitigated with appropriate analgesia, thereby avoiding unnecessary distress. Our objective was to compare the self-reported pain of IV catheter insertion in children when using a vibrating cold device (VCD) versus standard of care 4% topical lidocaine cream (TL).
Methods:
This was a 2-arm randomized controlled noninferiority trial with a convenience sample of 4- to 18-year-olds requiring nonemergent IV catheter insertion. Self-reported pain was measured with the Faces Pain Scale-Revised, anxiety with the Child's Rating of Anxiety scale, and observed pain with the Face, Legs, Activity, Crying, Consolability scale. Caregivers and nurses completed satisfaction surveys.
Results:
Two hundred twenty-four children were included in the analysis: 114 (90%) of 127 in the VCD group and 110 (89%) of 124 in the TL group. Faces Pain Scale-Revised scores for both groups were equivalent (median, 2.0 cm; interquartile range, 0-5 cm; linear regression difference, 0 [95% confidence interval, -0.82 to 0.82]), as were median Face, Legs, Activity, Crying, Consolability scale scores (difference, 0.33 [95% confidence interval, -0.01 to 0.68]). The time of completion for the IV procedure was significantly shorter for the VCD group compared with the TL group (median, 3.0 vs 40.5 minutes; P < 0.0001). There were no significant differences between groups for self-reported state or trait anxiety, success of IV catheter insertion on first attempt, or satisfaction of caregivers or staff.
Conclusions:
A VCD and TL showed equal effectiveness in reducing pain and distress for children undergoing IV catheter insertion. The VCD has the added benefit of quick onset time and an acceptable alternative for caregivers and nurses.
