Debra Ann Potts1, Katherine Finn Davis2, Okan U Elci3, Joel A Fein4. 1. From the Department of Nursing. 2. Center for Pediatric Nursing Research and Evidence-Based Practice, Department of Nursing. 3. Westat Biostatistics and Data Management Core (BDMC), and. 4. Division of Emergency Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.
Abstract
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.
RCT Entities:
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.
Authors: Leah I Stein Duker; Anita R Schmidt; Phung K Pham; Sofronia M Ringold; Alan L Nager Journal: Front Pediatr Date: 2021-01-05 Impact factor: 3.418